*Healthcare |
|
|
|
Biopharmaceuticals |
|
|
|
Allergies |
|
|
|
Upper Respiratory |
|
|
|
Antihistamines |
|
|
|
| Andrx Pharmaceuticals Loratadine Rapidly-Disintegrating Tablet |
Relief Of Allergic Rhinitis, Chronic Idiopathic Urticaria |
Headache, Fatigue, Dry Mouth, Somnolence, Nervousness |
Approved |
Antihistamines/Decongestants |
|
|
|
| Andrx Pharmaceuticals Loratadine/Pseudoephedrine Extended Release |
Nasal And Non-Nasal Seasonal Allergic Rhinitis (Hay Fever), Including Nasal Congestion |
Headache, Fatigue, Dry Mouth, Somnolence, Elevated Heartbeat, Dizziness |
Approved |
| Andrx Pharmaceuticals Loratadine/Pseudoephedrine Sulfate |
Relief Of Allergic Rhinitis, Chronic Idiopathic Urticaria |
Headache, Fatigue, Dry Mouth, Somnolence, Elevated Heartbeat, Dizziness |
Approved |
Cardiovascular System |
|
|
|
Heart Disorders |
|
|
|
Angina |
|
|
|
Beta Adrenergic Receptor Blocking Agents (Beta Blockers) |
|
|
|
| Andrx Pharmaceuticals Metoprolol Succinate |
Treatment Of Hypertension; Long-Term Treatment Of Angina Pectoris; Treatment Of Stable, Symptomatic Heart Failure Of Ischemic, Hypertensive, Or Cardiomyopathic Origin |
Tiredness, Dizziness, Depression, Shortness Of Breath, Bradycardia, Diarrhea, Pruritus, Rash |
ANDA/AADA Filed |
Calcium Channel Blocking Agents |
|
|
|
| Andrx Pharmaceuticals Cartia XT (Diltiazem HCl Extended-Release) |
Chronic Stable Angina, Hypertension |
Headache, Dizziness, Bradycardia, AV Block First-Degree, Edema |
Approved |
| Andrx Pharmaceuticals Diltia XT (Diltiazem HCl Extended-Release) |
Chronic Stable Angina, Hypertension |
Headache, Dizziness, Bradycardia, AV Block First-Degree, Edema |
Approved |
| Andrx Pharmaceuticals Taztia (Diltiazem HCl) |
Chronic Stable Angina, Hypertension |
Peripheral Edema, Dizziness, Pharyngitis, Infections, Vasodilation |
Approved |
| Andrx Pharmaceuticals Taztia XT (Diltiazem HCl Extended Release) |
Chronic Stable Angina, Hypertension |
|
Tentatively Approved |
Heart Failure (HF) |
|
|
|
Angiotensin Converting Enzyme Inhibitors (ACE Inhibitors) |
|
|
|
| Andrx Pharmaceuticals Monopril (Fosinopril Sodium) |
Hypertension, Adjunctive Therapy For Congestive Heart Failure (CHF) |
Cough, Dizziness, Nausea, Vomiting, Hypotension, Musculoskeletal Pain, Diarrhea |
Approved |
Beta Adrenergic Receptor Blocking Agents (Beta Blockers) |
|
|
|
| Andrx Pharmaceuticals Metoprolol Succinate |
Treatment Of Hypertension; Long-Term Treatment Of Angina Pectoris; Treatment Of Stable, Symptomatic Heart Failure Of Ischemic, Hypertensive, Or Cardiomyopathic Origin |
Tiredness, Dizziness, Depression, Shortness Of Breath, Bradycardia, Diarrhea, Pruritus, Rash |
ANDA/AADA Filed |
Vascular Disorders |
|
|
|
Atherosclerosis |
|
|
|
HMG CoA Reductase Inhibitors (Statins) |
|
|
|
| Andrx Pharmaceuticals Lovastatin |
Hypercholesterolemia, Coronary Atherosclerosis |
Headache, Rash/Pruritus, Abdominal Pains, Flatus, Diarrhea |
Approved |
Hypertension |
|
|
|
Angiotensin Converting Enzyme Inhibitors (ACE Inhibitors) |
|
|
|
| Andrx Pharmaceuticals Benazepril Hydrochloride |
Treatment Of Hypertension |
Headache, Dizziness, Fatigue, Somnolence, Postural Dizziness |
Approved |
| Andrx Pharmaceuticals Quinapril Hydrochloride |
Hypertension |
Coughing, Dizziness, Fatigue, Diarrhea |
Approved |
Angiotensin Converting Enzyme Inhibitors (ACE Inhibitors)/Thiazide Diuretic Agents |
|
|
|
| Andrx Pharmaceuticals Benazepril Hydrochloride/Hydrochlorothiazide |
Treatment Of Hypertension |
Dizziness, Fatigue, Postural Dizziness, Headache, Cough |
Approved |
| Andrx Pharmaceuticals Fosinopril Sodium/Hydrochlorothiazide |
Hypertension |
Headache, Cough, Fatigue, Dizziness, Upper Respiratory Infection, Musculoskeletal Pain |
Approved |
Beta Adrenergic Receptor Blocking Agents (Beta Blockers) |
|
|
|
| Andrx Pharmaceuticals Metoprolol Succinate |
Treatment Of Hypertension; Long-Term Treatment Of Angina Pectoris; Treatment Of Stable, Symptomatic Heart Failure Of Ischemic, Hypertensive, Or Cardiomyopathic Origin |
Tiredness, Dizziness, Depression, Shortness Of Breath, Bradycardia, Diarrhea, Pruritus, Rash |
ANDA/AADA Filed |
Calcium Channel Blocking Agents |
|
|
|
| Andrx Pharmaceuticals Cartia XT (Diltiazem HCl Extended-Release) |
Chronic Stable Angina, Hypertension |
Headache, Dizziness, Bradycardia, AV Block First-Degree, Edema |
Approved |
| Andrx Pharmaceuticals Diltia XT (Diltiazem HCl Extended-Release) |
Chronic Stable Angina, Hypertension |
Headache, Dizziness, Bradycardia, AV Block First-Degree, Edema |
Approved |
| Andrx Pharmaceuticals Taztia (Diltiazem HCl) |
Chronic Stable Angina, Hypertension |
Peripheral Edema, Dizziness, Pharyngitis, Infections, Vasodilation |
Approved |
Peripheral Vascular Disease |
|
|
|
Blood Viscosity Reducing Agents |
|
|
|
| Andrx Pharmaceuticals Cilostazol |
Intermittent Claudication Associated With Peripheral Vascular Disease |
Headache, Infection, Diarrhea, Abnormal Stools, Rhinitis |
Approved |
Digestive System |
|
|
|
Gastrointestinal Tract Disorders |
|
|
|
Gastroduodenal Disorders |
|
|
|
Peptic Ulcers |
|
|
|
Duodenal |
|
|
|
H2 Receptor Antagonists |
|
|
|
Proton Pump Inhibitors |
|
|
|
Gastric |
|
|
|
H2 Receptor Antagonists |
|
|
|
Proton Pump Inhibitors |
|
|
|
Zollinger-Ellison Syndrome |
|
|
|
H2 Receptor Antagonists |
|
|
|
Proton Pump Inhibitors |
|
|
|
Gastroesophageal Disorders |
|
|
|
Acid Indigestion/Heartburn |
|
|
|
H2 Receptor Antagonists |
|
|
|
| Andrx Pharmaceuticals Famotidine Tablets USP |
Short Term Treatment of Duodenal Ulcer, Gastric Ulcer, Gastroesophageal Reflux Disease (GERD), Esophagitis Due to GERD, Pathological Hypersecretory Conditions (eg. Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) |
Headache, Dizziness, Constipation, Diarrhea |
Approved |
Erosive Esophagitis |
|
|
|
Proton Pump Inhibitors |
|
|
|
| Andrx Pharmaceuticals Omeprazole |
Short-Term Treatment Of Active Duodenal Ulcer, Short-Term Treatment Of Active Benign Gastric Ulcer, Treatment Of Heartburn And Other Symptoms Associated With Gastroesophageal Reflux Disease (GERD), Short-Term Treatment Of Erosive Esophagitis, Maintain Healing Of Erosive Esophagitis, Long-Term Treatment Of Pathological Hypersecretory Conditions (Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas, Systemic Mastocytosis) |
Headache, Constipation, Cough, Dizziness, Rash |
Approved |
Gastroesophageal Reflux Disease (GERD) |
|
|
|
H2 Receptor Antagonists |
|
|
|
| Andrx Pharmaceuticals Famotidine Tablets USP |
Short Term Treatment of Duodenal Ulcer, Gastric Ulcer, Gastroesophageal Reflux Disease (GERD), Esophagitis Due to GERD, Pathological Hypersecretory Conditions (eg. Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) |
Headache, Dizziness, Constipation, Diarrhea |
Approved |
| Andrx Pharmaceuticals Famotidine Tablets USP |
Short Term Treatment of Duodenal Ulcer, Gastric Ulcer, Gastroesophageal Reflux Disease (GERD), Esophagitis Due to GERD, Pathological Hypersecretory Conditions (eg. Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) |
Headache, Dizziness, Constipation, Diarrhea |
Approved |
| Andrx Pharmaceuticals Famotidine Tablets USP |
Short Term Treatment of Duodenal Ulcer, Gastric Ulcer, Gastroesophageal Reflux Disease (GERD), Esophagitis Due to GERD, Pathological Hypersecretory Conditions (eg. Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) |
Headache, Dizziness, Constipation, Diarrhea |
Approved |
| Andrx Pharmaceuticals Famotidine Tablets USP |
Short Term Treatment of Duodenal Ulcer, Gastric Ulcer, Gastroesophageal Reflux Disease (GERD), Esophagitis Due to GERD, Pathological Hypersecretory Conditions (eg. Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) |
Headache, Dizziness, Constipation, Diarrhea |
Approved |
Proton Pump Inhibitors |
|
|
|
| Andrx Pharmaceuticals Omeprazole |
Short-Term Treatment Of Active Duodenal Ulcer, Short-Term Treatment Of Active Benign Gastric Ulcer, Treatment Of Heartburn And Other Symptoms Associated With Gastroesophageal Reflux Disease (GERD), Short-Term Treatment Of Erosive Esophagitis, Maintain Healing Of Erosive Esophagitis, Long-Term Treatment Of Pathological Hypersecretory Conditions (Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas, Systemic Mastocytosis) |
Headache, Constipation, Cough, Dizziness, Rash |
Approved |
| Andrx Pharmaceuticals Omeprazole |
Short-Term Treatment Of Active Duodenal Ulcer, Short-Term Treatment Of Active Benign Gastric Ulcer, Treatment Of Heartburn And Other Symptoms Associated With Gastroesophageal Reflux Disease (GERD), Short-Term Treatment Of Erosive Esophagitis, Maintain Healing Of Erosive Esophagitis, Long-Term Treatment Of Pathological Hypersecretory Conditions (Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas, Systemic Mastocytosis) |
Headache, Constipation, Cough, Dizziness, Rash |
Approved |
| Andrx Pharmaceuticals Omeprazole |
Short-Term Treatment Of Active Duodenal Ulcer, Short-Term Treatment Of Active Benign Gastric Ulcer, Treatment Of Heartburn And Other Symptoms Associated With Gastroesophageal Reflux Disease (GERD), Short-Term Treatment Of Erosive Esophagitis, Maintain Healing Of Erosive Esophagitis, Long-Term Treatment Of Pathological Hypersecretory Conditions (Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas, Systemic Mastocytosis) |
Headache, Constipation, Cough, Dizziness, Rash |
Approved |
| Andrx Pharmaceuticals Omeprazole |
Short-Term Treatment Of Active Duodenal Ulcer, Short-Term Treatment Of Active Benign Gastric Ulcer, Treatment Of Heartburn And Other Symptoms Associated With Gastroesophageal Reflux Disease (GERD), Short-Term Treatment Of Erosive Esophagitis, Maintain Healing Of Erosive Esophagitis, Long-Term Treatment Of Pathological Hypersecretory Conditions (Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas, Systemic Mastocytosis) |
Headache, Constipation, Cough, Dizziness, Rash |
Approved |
Endocrinology/Metabolism |
|
|
|
Diabetes |
|
|
|
Non-Insulin Dependent Diabetes Mellitus (NIDDM)/Type 2 Diabetes |
|
|
|
Biguanides |
|
|
|
| Andrx Pharmaceuticals Metformin Hydrochloride |
Non-Insulin Dependent Diabetes Mellitus (NIDDM)/Type 2 Diabetes |
Diarrhea, Nausea, Vomiting, Abdominal Bloating, Flatulence, Anorexia |
Approved |
| Andrx Pharmaceuticals Metformin Hydrochloride Extended Release |
Non-Insulin Dependent Diabetes Mellitus (NIDDM)/Type 2 Diabetes |
Diarrhea, Nausea, Vomiting, Abdominal Bloating, Flatulence, Anorexia |
Approved |
Biguanides/Peroxisome Proliferator-Activated Receptor Agonists (PPAR Agonists) |
|
|
|
| Andrx Laboratories ACTOplus met XR (Pioglitazone/Metformin Extended Release) |
Non-Insulin Dependent Diabetes Mellitus (NIDDM)/Type 2 Diabetes Who Are Not Controlled Adequately With Metformin Only |
|
NDA Filed |
Insulin Stimulating Agents (Sulfonylureas) |
|
|
|
| Andrx Pharmaceuticals Glipizide Extended Release |
Non-Insulin Dependent Diabetes Mellitus (NIDDM)/Type 2 Diabetes |
Fatigue, Headache, Dizziness, Nervousness, Diarrhea, Flatulence, Tremor |
Approved |
Hyperglycemia |
|
|
|
Insulin Stimulating Agents (Sulfonylureas) |
|
|
|
| Andrx Pharmaceuticals Glipizide Extended Release |
Non-Insulin Dependent Diabetes Mellitus (NIDDM)/Type 2 Diabetes |
Fatigue, Headache, Dizziness, Nervousness, Diarrhea, Flatulence, Tremor |
Approved |
Intermediary Metabolism Disorders |
|
|
|
Gout |
|
|
|
Gouty Arthritis |
|
|
|
Non-Steroidal Anti-Inflammatory Drugs (NSAID) |
|
|
|
Non-Specific Cyclooxygenase Inhibitors (COX Inhibitors) |
|
|
|
| Andrx Pharmaceuticals Naproxen Sodium |
Treatment Of Rheumatoid Arthritis (RA), Osteoarthritis (OA), Ankylosing Spondylitis, Tendinitis, Bursitis And Acute Gout, Relief Of Mild To Moderate Pain, Treatment Of Primary Dysmenorrhea |
Headache, Dyspepsia, Flu Syndrome |
Approved |
Hypercholesterolemia |
|
|
|
HMG CoA Reductase Inhibitors (Statins) |
|
|
|
| Andrx Pharmaceuticals Lovastatin |
Hypercholesterolemia, Coronary Atherosclerosis |
Headache, Rash/Pruritus, Abdominal Pains, Flatus, Diarrhea |
Approved |
Hematology |
|
|
|
Serum Factor Disorders |
|
|
|
Hypercholesterolemia |
|
|
|
HMG CoA Reductase Inhibitors (Statins) |
|
|
|
| Andrx Pharmaceuticals Lovastatin |
Hypercholesterolemia, Coronary Atherosclerosis |
Headache, Rash/Pruritus, Abdominal Pains, Flatus, Diarrhea |
Approved |
Hyperglycemia |
|
|
|
Insulin Stimulating Agents (Sulfonylureas) |
|
|
|
| Andrx Pharmaceuticals Glipizide Extended Release |
Non-Insulin Dependent Diabetes Mellitus (NIDDM)/Type 2 Diabetes |
Fatigue, Headache, Dizziness, Nervousness, Diarrhea, Flatulence, Tremor |
Approved |
Hypokalemia |
|
|
|
Potassium Supplements |
|
|
|
| Andrx Pharmaceuticals Potassium Chloride Extended Release |
Hypokalemia |
Nausea, Vomiting, Gas, Stomach Pain/Discomfort, Diarrhea |
Approved |
Immunology |
|
|
|
Autoimmune Disorders |
|
|
|
Arthritis |
|
|
|
Rheumatoid Arthritis (RA) |
|
|
|
Analgesics |
|
|
|
Non-Steroidal Anti-Inflammatory Drugs (NSAID) |
|
|
|
Non-Specific Cyclooxygenase Inhibitors (COX Inhibitors) |
|
|
|
| Andrx Pharmaceuticals Etodolac Extended Release |
Acute And Long Term Use In The Management Of The Signs And Symptoms Of Osteoarthritis (OA) And Rheumatoid Arthritis (RA) |
Chills, Fever, Dyspepsia, Abdominal Pain, Asthenia, Malaise, Pruritis, Blurred Vision, Dysuria |
Approved |
| Andrx Pharmaceuticals Ketoprofen Extended Release |
Rheumatoid Arthritis (RA), Osteoarthritis (OA) |
Dyspepsia, Nausea, Abdominal Pain, Diarrhea, Constipation, Flatulence, Headache, Insomnia, Nervousness, Impairment Of Renal Function |
Approved |
| Andrx Pharmaceuticals Naproxen Sodium |
Treatment Of Rheumatoid Arthritis (RA), Osteoarthritis (OA), Ankylosing Spondylitis, Tendinitis, Bursitis And Acute Gout, Relief Of Mild To Moderate Pain, Treatment Of Primary Dysmenorrhea |
Headache, Dyspepsia, Flu Syndrome |
Approved |
Infectious Diseases |
|
|
|
Bacterial |
|
|
|
Antibacterial Agents |
|
|
|
Broad Spectrum |
|
|
|
Antibiotics |
|
|
|
Macrolides |
|
|
|
| Andrx Pharmaceuticals Clarithromycin Extended Release |
Treatment Of Mild To Moderate Infections For Acute Maxillary Sinusitis (AMS), Acute Bacterial Exacerbation Of Chronic Bronchitis (AECB) |
Diarrhea, Abnormal Taste, Nausea |
Approved |
Mycological (Fungal) |
|
|
|
Antifungal Agents |
|
|
|
Narrow Spectrum |
|
|
|
Dermatology |
|
|
|
Onychomycosis (Nail) |
|
|
|
Amine Derivatives |
|
|
|
Allyl |
|
|
|
| Andrx Pharmaceuticals Terbinafine Hydrochloride |
Treatment Of Onychomycosis Of The Toenail Or Fingernail Due To Dermatophytes (Tinea Unguium) |
Diarrhea, Rash, Dyspepsia, Liver Enzyme Abnormalities, Taste Disturbance, Pruritus, Nausea, Abdominal Pain |
Tentatively Approved |
Musculoskeletal System |
|
|
|
Skeletal Disorders |
|
|
|
Joint Disorders |
|
|
|
Ankylosing Spondylitis |
|
|
|
Non-Steroidal Anti-Inflammatory Drugs (NSAID) |
|
|
|
Non-Specific Cyclooxygenase Inhibitors (COX Inhibitors) |
|
|
|
| Andrx Pharmaceuticals Naproxen Sodium |
Treatment Of Rheumatoid Arthritis (RA), Osteoarthritis (OA), Ankylosing Spondylitis, Tendinitis, Bursitis And Acute Gout, Relief Of Mild To Moderate Pain, Treatment Of Primary Dysmenorrhea |
Headache, Dyspepsia, Flu Syndrome |
Approved |
Gouty Arthritis |
|
|
|
Non-Steroidal Anti-Inflammatory Drugs (NSAID) |
|
|
|
Non-Specific Cyclooxygenase Inhibitors (COX Inhibitors) |
|
|
|
Osteoarthritis (OA) |
|
|
|
Non-Steroidal Anti-Inflammatory Drugs (NSAID) |
|
|
|
Non-Specific Cyclooxygenase Inhibitors (COX Inhibitors) |
|
|
|
| Andrx Pharmaceuticals Etodolac Extended Release |
Acute And Long Term Use In The Management Of The Signs And Symptoms Of Osteoarthritis (OA) And Rheumatoid Arthritis (RA) |
Chills, Fever, Dyspepsia, Abdominal Pain, Asthenia, Malaise, Pruritis, Blurred Vision, Dysuria |
Approved |
| Andrx Pharmaceuticals Ketoprofen Extended Release |
Rheumatoid Arthritis (RA), Osteoarthritis (OA) |
Dyspepsia, Nausea, Abdominal Pain, Diarrhea, Constipation, Flatulence, Headache, Insomnia, Nervousness, Impairment Of Renal Function |
Approved |
| Andrx Pharmaceuticals Naproxen Sodium |
Treatment Of Rheumatoid Arthritis (RA), Osteoarthritis (OA), Ankylosing Spondylitis, Tendinitis, Bursitis And Acute Gout, Relief Of Mild To Moderate Pain, Treatment Of Primary Dysmenorrhea |
Headache, Dyspepsia, Flu Syndrome |
Approved |
Rheumatoid Arthritis (RA) |
|
|
|
Analgesics |
|
|
|
Non-Steroidal Anti-Inflammatory Drugs (NSAID) |
|
|
|
Non-Specific Cyclooxygenase Inhibitors (COX Inhibitors) |
|
|
|
| Andrx Pharmaceuticals Etodolac Extended Release |
Acute And Long Term Use In The Management Of The Signs And Symptoms Of Osteoarthritis (OA) And Rheumatoid Arthritis (RA) |
Chills, Fever, Dyspepsia, Abdominal Pain, Asthenia, Malaise, Pruritis, Blurred Vision, Dysuria |
Approved |
| Andrx Pharmaceuticals Ketoprofen Extended Release |
Rheumatoid Arthritis (RA), Osteoarthritis (OA) |
Dyspepsia, Nausea, Abdominal Pain, Diarrhea, Constipation, Flatulence, Headache, Insomnia, Nervousness, Impairment Of Renal Function |
Approved |
| Andrx Pharmaceuticals Naproxen Sodium |
Treatment Of Rheumatoid Arthritis (RA), Osteoarthritis (OA), Ankylosing Spondylitis, Tendinitis, Bursitis And Acute Gout, Relief Of Mild To Moderate Pain, Treatment Of Primary Dysmenorrhea |
Headache, Dyspepsia, Flu Syndrome |
Approved |
| Andrx Pharmaceuticals Naproxen Sodium |
Treatment Of Rheumatoid Arthritis (RA), Osteoarthritis (OA), Ankylosing Spondylitis, Tendinitis, Bursitis And Acute Gout, Relief Of Mild To Moderate Pain, Treatment Of Primary Dysmenorrhea |
Headache, Dyspepsia, Flu Syndrome |
Approved |
Neurology |
|
|
|
Neurological Disorders |
|
|
|
Epilepsy |
|
|
|
Partial Seizures |
|
|
|
Complex |
|
|
|
Adjunctive Therapy |
|
|
|
Gamma-Aminobutyric Acid (GABA) Reuptake Inhibitors |
|
|
|
| Andrx Laboratories Valproate Delayed Release Tablet (Divalproex) |
Monotherapy and Adjunctive Therapy for Complex Partial Seizures, Absence Pattern Epileptic Seizure, Mixed Pattern Seizure Epilepsy, Manic Episodes Associated With Bipolar Disorder |
|
Approvable Letter Received |
| Andrx Pharmaceuticals Gabapentin |
Adjunctive Therapy For Partial Seizures With/Without Secondary Generalization In Adults With Epilepsy, Post-Herpetic Neuralgia (Chronic Neuropathic Pain) |
Fatigue, Dizziness, Somnolence, Ataxia |
Approved |
Monotherapy |
|
|
|
Gamma-Aminobutyric Acid (GABA) Reuptake Inhibitors |
|
|
|
| Andrx Laboratories Valproate Delayed Release Tablet (Divalproex) |
Monotherapy and Adjunctive Therapy for Complex Partial Seizures, Absence Pattern Epileptic Seizure, Mixed Pattern Seizure Epilepsy, Manic Episodes Associated With Bipolar Disorder |
|
Approvable Letter Received |
| Andrx Laboratories Valproate Delayed Release Tablet (Divalproex) |
Monotherapy and Adjunctive Therapy for Complex Partial Seizures, Absence Pattern Epileptic Seizure, Mixed Pattern Seizure Epilepsy, Manic Episodes Associated With Bipolar Disorder |
|
Approvable Letter Received |
Primary Generalized Seizures |
|
|
|
Absence (Petit Mal) |
|
|
|
Adjunctive Therapy |
|
|
|
Gamma-Aminobutyric Acid (GABA) Reuptake Inhibitors |
|
|
|
Monotherapy |
|
|
|
Gamma-Aminobutyric Acid (GABA) Reuptake Inhibitors |
|
|
|
| Andrx Laboratories Valproate Delayed Release Tablet (Divalproex) |
Monotherapy and Adjunctive Therapy for Complex Partial Seizures, Absence Pattern Epileptic Seizure, Mixed Pattern Seizure Epilepsy, Manic Episodes Associated With Bipolar Disorder |
|
Approvable Letter Received |
Headaches |
|
|
|
Vascular (Migraine) |
|
|
|
Prophylactic Treatments |
|
|
|
Gamma-Aminobutyric Acid (GABA) Reuptake Inhibitors |
|
|
|
| Andrx Laboratories Valproate Delayed Release Tablet (Divalproex) |
Monotherapy and Adjunctive Therapy for Complex Partial Seizures, Absence Pattern Epileptic Seizure, Mixed Pattern Seizure Epilepsy, Manic Episodes Associated With Bipolar Disorder |
|
Approvable Letter Received |
Psychiatric Disorders |
|
|
|
Anxiety |
|
|
|
Generalized Anxiety Disorder (GAD) |
|
|
|
Selective Serotonin Reuptake Inhibitors (SSRI) |
|
|
|
| Andrx Pharmaceuticals Paroxetine Hydrochloride |
Generalized Anxiety Disorder |
|
ANDA/AADA Filed |
Obsessive Compulsive Disorder (OCD) |
|
|
|
Selective Serotonin Reuptake Inhibitors (SSRI) |
|
|
|
| Andrx Pharmaceuticals Fluoxetine Hydrochloride |
Treatment Of Depression And Obsessive Compulsive Disorder (OCD) In Adults, Geriatrics And Children Older Than 7 Years Of Age, Bulimia |
Insomnia, Anxiety, Somnolence, Tremor, Nausea, Dyspepsia, Asthenia |
Approved |
| Andrx Pharmaceuticals Paroxetine Hydrochloride |
Obsessive Compulsive Disorder (OCD) |
|
ANDA/AADA Filed |
| Andrx Pharmaceuticals Sertraline Hydrochloride |
Depression, Obsessive-Compulsive Disorder (OCD), Panic Disorder And Post-Traumatic Stress Disorder (PTSD), Social Anxiety Disorder, Premenstrual Dysphoric Disorder (PMDD) |
Nausea, Diarrhea/Loose Stools, Insomnia, Somnolence, Dyspepsia |
Tentatively Approved |
Panic Disorder |
|
|
|
Selective Serotonin Reuptake Inhibitors (SSRI) |
|
|
|
| Andrx Pharmaceuticals Paroxetine Hydrochloride |
Panic Disorder |
|
ANDA/AADA Filed |
| Andrx Pharmaceuticals Sertraline Hydrochloride |
Depression, Obsessive-Compulsive Disorder (OCD), Panic Disorder And Post-Traumatic Stress Disorder (PTSD), Social Anxiety Disorder, Premenstrual Dysphoric Disorder (PMDD) |
Nausea, Diarrhea/Loose Stools, Insomnia, Somnolence, Dyspepsia |
Tentatively Approved |
Post-Traumatic Stress Disorder (PTSD) |
|
|
|
Selective Serotonin Reuptake Inhibitors (SSRI) |
|
|
|
| Andrx Pharmaceuticals Paroxetine Hydrochloride |
Posttraumatic Stress Disorder |
|
ANDA/AADA Filed |
| Andrx Pharmaceuticals Sertraline Hydrochloride |
Depression, Obsessive-Compulsive Disorder (OCD), Panic Disorder And Post-Traumatic Stress Disorder (PTSD), Social Anxiety Disorder, Premenstrual Dysphoric Disorder (PMDD) |
Nausea, Diarrhea/Loose Stools, Insomnia, Somnolence, Dyspepsia |
Tentatively Approved |
Social Anxiety Disorder (SAD) |
|
|
|
Selective Serotonin Reuptake Inhibitors (SSRI) |
|
|
|
| Andrx Pharmaceuticals Paroxetine Hydrochloride |
Social Anxiety Disorder |
|
ANDA/AADA Filed |
| Andrx Pharmaceuticals Sertraline Hydrochloride |
Depression, Obsessive-Compulsive Disorder (OCD), Panic Disorder And Post-Traumatic Stress Disorder (PTSD), Social Anxiety Disorder, Premenstrual Dysphoric Disorder (PMDD) |
Nausea, Diarrhea/Loose Stools, Insomnia, Somnolence, Dyspepsia |
Tentatively Approved |
Childhood/Adolescent Disorders |
|
|
|
Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD) |
|
|
|
Dopamine Receptor Blocking Agents |
|
|
|
| Andrx Pharmaceuticals Methylphenidate Hydrochloride |
Once-Daily Treatment For Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD) |
Headache, Upper Respiratory Tract Infection, Stomach Pain, Vomiting, Coughing |
ANDA/AADA Filed |
Eating Disorders |
|
|
|
Bulimia |
|
|
|
Selective Serotonin Reuptake Inhibitors (SSRI) |
|
|
|
| Andrx Pharmaceuticals Fluoxetine Hydrochloride |
Treatment Of Depression And Obsessive Compulsive Disorder (OCD) In Adults, Geriatrics And Children Older Than 7 Years Of Age, Bulimia |
Insomnia, Anxiety, Somnolence, Tremor, Nausea, Dyspepsia, Asthenia |
Approved |
Mood Disorders |
|
|
|
Bipolar Disorders (Manic Depressive Disorders) |
|
|
|
Gamma-Aminobutyric Acid (GABA) Reuptake Inhibitors |
|
|
|
| Andrx Laboratories Valproate Delayed Release Tablet (Divalproex) |
Monotherapy and Adjunctive Therapy for Complex Partial Seizures, Absence Pattern Epileptic Seizure, Mixed Pattern Seizure Epilepsy, Manic Episodes Associated With Bipolar Disorder |
|
Approvable Letter Received |
Depression |
|
|
|
Selective Serotonin Reuptake Inhibitors (SSRI) |
|
|
|
| Andrx Pharmaceuticals Fluoxetine Hydrochloride |
Treatment Of Depression And Obsessive Compulsive Disorder (OCD) In Adults, Geriatrics And Children Older Than 7 Years Of Age, Bulimia |
Insomnia, Anxiety, Somnolence, Tremor, Nausea, Dyspepsia, Asthenia |
Approved |
| Andrx Pharmaceuticals Paroxetine Hydrochloride |
Depression |
|
ANDA/AADA Filed |
| Andrx Pharmaceuticals Sertraline Hydrochloride |
Depression, Obsessive-Compulsive Disorder (OCD), Panic Disorder And Post-Traumatic Stress Disorder (PTSD), Social Anxiety Disorder, Premenstrual Dysphoric Disorder (PMDD) |
Nausea, Diarrhea/Loose Stools, Insomnia, Somnolence, Dyspepsia |
Tentatively Approved |
Tetracyclic Compounds |
|
|
|
| Andrx Pharmaceuticals Mirtazapine |
Treatment Of Depression |
Somnolence, Nausea, Increased Appetite, Weight Gain, Dizziness, Dry Mouth, Constipation |
Approved |
Premenstrual Dysphoric Disorders |
|
|
|
Selective Serotonin Reuptake Inhibitors (SSRI) |
|
|
|
| Andrx Pharmaceuticals Sertraline Hydrochloride |
Depression, Obsessive-Compulsive Disorder (OCD), Panic Disorder And Post-Traumatic Stress Disorder (PTSD), Social Anxiety Disorder, Premenstrual Dysphoric Disorder (PMDD) |
Nausea, Diarrhea/Loose Stools, Insomnia, Somnolence, Dyspepsia |
Tentatively Approved |
Obstetrics/Gynecology |
|
|
|
Child Birth/Pregnancy |
|
|
|
Prevention (Contraception) |
|
|
|
Contraceptives (Birth Control) |
|
|
|
Estrogens/Progestins |
|
|
|
| Andrx Pharmaceuticals Norethindrone/Ethinyl Estradiol/Ferrous Fumarate |
Prevention Of Pregnancy |
Vaginal Bleeding, Edema, Melasma, Nausea, Vomiting, Change In Appetite, Headache, Nervousness, Depression, Dizziness, Loss Of Scalp Hair, Rash, Vaginal Infections |
ANDA/AADA Filed |
| Andrx Pharmaceuticals Previfem (Norgestimate/Ethinyl Estradiol) |
Prevention Of Pregnancy |
Vaginal Bleeding, Edema, Melasma, Nausea, Vomiting, Change In Appetite, Headache, Nervousness, Depression, Dizziness, Loss Of Scalp Hair, Rash, Vaginal Infections |
Approved |
| Andrx Pharmaceuticals Tri-Previfem (Norgestimate/Ethinyl Estradiol) |
Prevention Of Pregnancy |
Vaginal Bleeding, Edema, Melasma, Nausea, Vomiting, Change In Appetite, Headache, Nervousness, Depression, Dizziness, Loss Of Scalp Hair, Rash, Vaginal Infections |
Approved |
Pain Management |
|
|
|
Narcotics |
|
|
|
Analgesics/Opioids |
|
|
|
| Andrx Pharmaceuticals Acetaminophen/Tramadol Hydrochloride |
Short Term Management Of Acute Pain |
Constipation, Diarrhea, Nausea, Dry Mouth, Somnolence, Anorexia, Insomnia, Dizziness, Increased Sweating |
Approved |
| Andrx Pharmaceuticals Codeine Phosphate/Acetaminophen |
Relief Of Mild To Moderate Pain |
Lightheadedness, Dizziness, Sedation, Shortness Of Breath, Nausea And Vomiting |
Approved |
| Andrx Pharmaceuticals Ibuprofen/Hydrocodone Bitartrate |
Short-Term Management Of Acute Pain |
Headaches, Somnolence, Dizziness, Diarrhea, Dyspepsia, Nausea |
Approved |
| Andrx Pharmaceuticals Propoxyphene Hydrochloride/Acetaminophen |
Mild To Moderate Pain |
Dizziness, Drowsiness, Nausea, Unusual Tiredness, Stomach Discomfort |
Approved |
| Anexsia (Acetaminophen/Hydrocodone Bitartrate) |
Moderate To Moderately Severe Pain |
Lightheadedness, Dizziness, Nausea, Vomiting, Sedation |
Approved |
Opioids |
|
|
|
| Andrx Pharmaceuticals Fentanyl |
Chronic Pain |
Nausea, Constipation, Dry Mouth, Somnolence, Confusion, Asthenia, Sweating |
Approved |
| Andrx Pharmaceuticals Oxycodone HCl Extended Release |
Moderate to Moderately Severe Pain |
Lightheadedness, Dizziness, Sedation, Nausea, Vomiting |
Approved |
Non-Narcotics |
|
|
|
Non-Steroidal Anti-Inflammatory Drugs (NSAID) |
|
|
|
Non-Specific Cyclooxygenase Inhibitors (COX Inhibitors) |
|
|
|
| Andrx Pharmaceuticals Naproxen Sodium |
Treatment Of Rheumatoid Arthritis (RA), Osteoarthritis (OA), Ankylosing Spondylitis, Tendinitis, Bursitis And Acute Gout, Relief Of Mild To Moderate Pain, Treatment Of Primary Dysmenorrhea |
Headache, Dyspepsia, Flu Syndrome |
Approved |
Respiratory System |
|
|
|
Lower Respiratory Tract Disorders (Lung Disorders) |
|
|
|
Asthma |
|
|
|
Acute Treatments |
|
|
|
Bronchodilators |
|
|
|
Beta Adrenergic Receptor Agonists |
|
|
|
| Andrx Pharmaceuticals Albuterol Inhalation Aerosol |
Prevention And Relief Of Bronchospasm In Patients With Reversible Obstructive Airway Disease, Prevention Of Exercise-Induced Bronchospasm |
Tremor, Nausea, Tachycardia, Nervousness, Palpitations |
Approved |
| Armstrong Pharmaceuticals Albuterol MDI |
Prevention And Relief Of Bronchospasm In Patients With Reversible Obstructive Airway Disease, Prevention Of Exercise-Induced Bronchospasm |
Tremor, Nausea, Palpitations, Nervousness, Increased Blood Pressure, Dizziness, Heartburn, Tachycardia |
Approved |
Bronchitis |
|
|
|
Acute Treatments |
|
|
|
Bronchodilators |
|
|
|
Beta Adrenergic Receptor Agonists |
|
|
|
| Andrx Pharmaceuticals Albuterol Inhalation Aerosol |
Prevention And Relief Of Bronchospasm In Patients With Reversible Obstructive Airway Disease, Prevention Of Exercise-Induced Bronchospasm |
Tremor, Nausea, Tachycardia, Nervousness, Palpitations |
Approved |
| Armstrong Pharmaceuticals Albuterol MDI |
Prevention And Relief Of Bronchospasm In Patients With Reversible Obstructive Airway Disease, Prevention Of Exercise-Induced Bronchospasm |
Tremor, Nausea, Palpitations, Nervousness, Increased Blood Pressure, Dizziness, Heartburn, Tachycardia |
Approved |
Bronchospasm |
|
|
|
Bronchodilators |
|
|
|
Beta Adrenergic Receptor Agonists |
|
|
|
| Andrx Pharmaceuticals Albuterol Inhalation Aerosol |
Prevention And Relief Of Bronchospasm In Patients With Reversible Obstructive Airway Disease, Prevention Of Exercise-Induced Bronchospasm |
Tremor, Nausea, Tachycardia, Nervousness, Palpitations |
Approved |
| Armstrong Pharmaceuticals Albuterol MDI |
Prevention And Relief Of Bronchospasm In Patients With Reversible Obstructive Airway Disease, Prevention Of Exercise-Induced Bronchospasm |
Tremor, Nausea, Palpitations, Nervousness, Increased Blood Pressure, Dizziness, Heartburn, Tachycardia |
Approved |
Chronic Obstructive Pulmonary Disease (COPD) |
|
|
|
Acute Treatments |
|
|
|
Bronchodilators |
|
|
|
Beta Adrenergic Receptor Agonists |
|
|
|
| Andrx Pharmaceuticals Albuterol Inhalation Aerosol |
Prevention And Relief Of Bronchospasm In Patients With Reversible Obstructive Airway Disease, Prevention Of Exercise-Induced Bronchospasm |
Tremor, Nausea, Tachycardia, Nervousness, Palpitations |
Approved |
| Armstrong Pharmaceuticals Albuterol MDI |
Prevention And Relief Of Bronchospasm In Patients With Reversible Obstructive Airway Disease, Prevention Of Exercise-Induced Bronchospasm |
Tremor, Nausea, Palpitations, Nervousness, Increased Blood Pressure, Dizziness, Heartburn, Tachycardia |
Approved |
Upper Respiratory Tract Disorders |
|
|
|
Coughs/Colds |
|
|
|
Decongestants/Expectorants |
|
|
|
| Andrx Laboratories Entex LA (Phenylephrine Hydrochloride/Guaifenesin) |
Temporary Relief Of Symptoms Associated With The Common Cold, Influenza, Sinusitis, And Bronchitis
|
Tachycardia, Palpitations, Headache, Dizziness, Or Nausea |
Approved |
| Andrx Laboratories Pseudoephedrine Extended Release/Guaifenesin Capsules |
Temporary Relief Of Symptoms Associated With The Common Cold, Influenza, Sinusitis, And Bronchitis |
Tachycardia, Palpitations, Headache, Dizziness, Nausea |
Approved |
| Andrx Pharmaceuticals Phenylephrine Hydrochloride/Guaifenesin |
Temporary Relief Of Symptoms Associated With The Common Cold, Influenza, Sinusitis, And Bronchitis |
Tachycardia, Palpitations, Headache, Dizziness, Or Nausea |
Approved |
Toxicology |
|
|
|
Substance Abuse |
|
|
|
Withdrawal |
|
|
|
Nicotine (Smoking Cessation) |
|
|
|
Serotonin/Norepinephrine Reuptake Inhibitors |
|
|
|
| Andrx Pharmaceuticals Bupropion Hydrochloride |
Aid To Smoking Cessation |
Insomnia, Dry Mouth |
Tentatively Approved |
Healthcare Services |
|
|
|
Distributors |
|
|
|
Pharmaceutical |
|
|
|
Specialty/Generic |
|
|
|
Nutritional Health |
|
|
|
Dietary/Naturopathic Supplements |
|
|
|
Women`s Health |
|
|
|
Outsourced Services |
|
|
|
Development/Manufacturing Services |
|
|
|
Contract Manufacturing Organizations (CMO) |
|
|
|
Pharmaceuticals |
|
|
|
Active/Intermediate Chemicals |
|
|
|
Drug Delivery Technology |
|
|
|
Oral Delivery |
|
|
|
Hydrogel Based |
|
|
|
Hydrogel Based/Polymer Coated |
|
|
|
Osmotic |
|
|
|
Polymer Coated |
|
|
|