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FDA Approval Activities for this Drug…
Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb NDA 19-898/S054 9/5/03 9/25/03 9/25/03 | Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb NDA 19-898/S052 10/29/02 11/18/02 10/29/02 | Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb NDA 19-898/S050 7/12/02 7/15/02 7/12/02 | Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb NDA 19-898/S042 6/22/01 11/6/01 11/6/01 | Pravachol/Pravastatin Sodium Tablets, Bristol-Myers Squibb NDA 19-898/S034 10/14/99 10/15/99 2/22/00 | Pravachol (pravastatin) Tablets, Bristol-Myers Squibb NDA 19-898/S-032 2/10/00 2/14/00 12/11/01 | Pravachol Indications: This supplemental new drug application provides for a new indication, based on the results of the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) study, for the use of | pravastatin in patients with evident coronary heart disease to reduce | the risk of total mortality by reducing coronary death. In addition, this supplemental application provides for changes to the CLINICAL PHARMACOLOGY and PRECAUTIONS sections of the Pravachol package insert. | Pravachol (pravastatin) Tablets,Rx Bristol-Myers Squibb NDA 19-898/S-031 6/9/00 6/12/00 | Pravachol Indications: This supplemental new drug application provides for the additional indication of increasing HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb). | Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb NDA 19-898/S018 3/27/98 5/22/01 | Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb NDA 19-898/S020 3/11/98 5/22/01 | Pravachol/Pravastatin Sodium Tablets, Bristol-Myers Squibb 19-898/S026, S027, S029, S030 1/18/00 1/21/00 | Pravachol/Pravastatin Sodium Tablets, Bristol-Myers Squibb 19-898/S026, S027, S029, S030 1/18/00 1/21/00 | Pravachol Indications: These supplemental new drug applications provide for new indications for the use of Pravachol (pravastatin) tablets in the treatment of patients with Frederickson Type IV (S-026) and in the treatment of patients with Frederickson Type III (S-027). In addition, they provide for an optional starting dose of 40 mg/day (S-029) and for a change in the recommended time of dosing from administration at bedtime to administration at any time of day with or without food (S-030). 5. It is a prescription drug. | Pravachol (Pravastatin) Tablets, Bristol-Myers Squibb 19-898/S034 10/14/99 7/6/00 | Pravachol (Pravastatin) Tablets, Bristol-Myers Squibb 19-898/S037 6/23/00 | Pravachol Indications: Change to the Clinical Pharmacology, Pharmacokinetics/Metabolism subsection regarding age-relatd differences in mean AUC and mean cumulative urinary excretion of pravastatin and for the addition of a "Geriatric Use" subsection to the Precautions section of the Provachol package insert. | Pravachol (Pravastatin) Tablets, Bristol-Myers Squibb 19-898/S046 12/18/01 5/1/02 1/25/02 | Pravastatin Sodium Tablets, 10, 20 40 & 80 mg, Ranbaxy ANDA 76-445 9/30/03 | Pravastatin Sodium Tablets, 10, 20 & 40 mg, LEK ANDA 76-397 6/26/03 | Pravastatin Sodium Tablets, 10, 20 & 40 mg, Apotex ANDA 76-341 9/30/03 | Pravastatin Sodium Tablets, 10, 20, 40 & 80 mg, Geneva ANDA 76-279 1/30/03 | Pravastatin Sodium Tablets, 10, 20 & 40 mg, Ivax ANDA 76-199 7/31/03 | Pravastatin Sodium Tablets, 10, 20 & 40 mg, Teva ANDA 76-056 Pravigard PAC (co-packaged 20, 40 or 80 mg pravastatin sodium and 81 or 325 mg buffered aspirin) Tablets, Bristol-Myers Squibb Company NDA 21-387 | Pravastatin Sodium Tablets, Genpharm, Tentative Approval | Pravachol (pravastatin sodium) Tablets, Bristol-Myers Squibb, Labeling Revision | Pravastatin Sodium Tablets, Dr. Reddy’s, Tentative Approval | Pravastatin Sodium Tablets, Teva Pharma, Approval | Pravastatin Sodium Tablets, Watson Labs, Tentative Approval | Pravastatin Sodium Tablets, Zydus Pharma, Tentative Approval | Pravastatin Sodium Tablets, Teva Pharma, Labeling Revision | Pravastatin Sodium Tablets, Lek Pharma, Approval | Pravastatin Sodium Tablets, Genpharm Inc., Approval/Tentative Approval | Pravastatin Sodium Tablets, Watson Labs, Approval/Tentative Approval | Pravastatin Sodium Tablets, Cobalt Pharma, Approval/Tentative Approval | Pravastatin Sodium Tablets, Dr. Reddy’s Labs, Approval/Tentative Approval | Pravastatin Sodium Tablets, Apotex Inc., Approval/Tentative Approval | Pravastatin Sodium Tablets, Lek Pharma, Tentative Approval | Pravastatin Sodium Tablets, Teva Pharma, Tentative Approval | Pravachol (pravastatin sodium) Tablets, Bristol Myers Squibb, Efficacy Supp. w/Clinical Data | Pravastatin Sodium Tablets, Ranbaxy, Approval | Pravastatin Sodium Tablets, Glenmark Pharma, Control Supplement | Pravastatin Sodium Tablets, Cobalt Labs, Control Supplement | Pravastatin Sodium Tablets, Lupin, Approval | Pravastatin Sodium Tablets, Teva Pharma, Approval | Pravastatin Sodium Tablets, Lek Pharma, Approval | Pravastatin Sodium Tablets, Zydus Pharmaceuticals, Approval | Pravastatin Sodium Tablets, Matrix Laboratories Ltd., Approval | Pravachol (pravastatin sodium) Tablets, Bristol-Myers Squibb Co., Labeling Revision
  
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