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FDA Approval Activities for this Drug…
Simvastatin Tablets, Ranbaxy ANDA 76-285 Zocor (Simvastatin) Tablets, Merck NDA 19-766/S-027 3/31/98 5/6/98 4/30/02 Zocor (simvastatin) Tablets, Merck NDA 19-766/ S-026, S-028 7/10/98 7/10/98 11/12/98 Zocor indication: These supplemental new drug applications provide for the use of a new dosage strength and dosing regimen (80 mg per day) of Zocor, (S-028) and for a new indication for the treatment of patients with homozygous familial hypercholesterolemia (S-026). Zocor (simvastatin) Tablets, Merck NDA 19-766/ S-029 6/29/98 10/23/98 Zocor (simvastatin) Tablets, Merck NDA 19-766/ S-032 8/5/99 8/6/99 Zocor Indication (S32): 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). The revised first paragraph of the "Hyperlipidemia" subsection of INDICATIONS AND USAGE will state "Zocor is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and TG levels, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial andnonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb)." Zocor (simvastatin) Tablets, Merck NDA 19-766/ | S-034 & S-036 11/22/99 7/6/00, 7/6/00 | Zocor (simvastatin) Tablets, Merck NDA 19-766/ | S-040 4/27/00 4/28/00 6/4/01 | Zocor (simvastatin) Tablets, Merck NDA 19-766/ | S-042 11/7/00 | Zocor (simvastatin) Tablets, Merck & Co., NDA 19-766/S51 5/6/02 5/9/02 5/6/02 | Zocor (simvastatin) Tablets, Merck & Co., NDA 19-766/S52 3/21/02 3/29/02 3/21/02 7/5/02 | Zocor (simvastatin) Tablets, Merck & Co., NDA 19-766/S53 11/14/01 6/16/03 | Zocor (simvastatin) Tablets, Merck & Co., NDA 19-766/S56 10/18/02 10/28/02 10/18/02 | Zocor (simvastatin) Tablets, Merck & Co., NDA 19-766/S58 4/16/03 4/17/03 | Zocor (simvastatin) Tablets, Merck & Co., NDA 19-766/S65 & S66 | Zocor (Simvastatin) Tablets, Merck Vytorin (ezetimibe/simvastatin) Tablets, MSP Singapore Company, Approval | Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Inc., Package Change | Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Labeling Revision | Zocor (simvastatin) Tablets, Merck & Co., Labeling Revision | Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Labeling Revision | Zocor (simvastatin) Tablets, Merck & Co., Labeling Revision | Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Labeling Revision | Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Control Supplement | Simvastatin Tablets, Teva Pharma, Tentative Approval | Simvastatin Tablets, Cobalt Pharma, Tentative Approval | Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Comparative Efficacy | Simvastatin Tablets, Aurobindo Pharma, Tentative Approval | Simvastatin Tablets, Ivax Pharma, Tentative Approval | Simvastatin Tablets (5,10,20&40mg), Ivax Pharma, Approval & Tentative Approval | Simvastatin Tablets(80mg), Ranbaxy Labs, Approval & Tentative Approval | Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Labeling Revision | Simvastatin Tablets, Cobalt Pharma, Tentative Approval | Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Comparative Efficacy Claim | Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Labeling Revision | Simvastatin Tablets, Zydus Pharma, Tentative Approval | Simvastatin Tablets, Sandoz, Inc., Tentative Approval | Vytorin (ezetimibe/simvastatin) Tablets, MSP Singapore Co. LLC., Manufacturing Change or Addition | Simvastatin Tablets, Dr. Reddy’s Labs, Tentative Approval | Simvastatin Tablets, Cobalt Pharma, Approval | Simvastatin Tablets, Aurobindo Pharma, Approval | Simvastatin Tablets, Zydus Pharma, Approval | Simvastatin Tablets, Sandoz Inc., Approval | Simvastatin Tablets, Dr. Reddy’s Labs, Approval | Simvastatin Tablets, Perrigo R & D Co., Approval | Simvastatin Tablets, Ivax Pharma, New Strength | Simvastatin Tablets, Ranbaxy Labs, New Strength | Vytorin (ezetimibe/simvastatin) Tablets, MSP Singapore, Labeling Revision | Zocor (simvastatin) Tablets, Merck & Co., Control Supplement | Simvastatin Tablets, Dr. Reddy’s Labs, Approval | Simvastatin Orally Disintegrating Tablets, Synthon Pharma, Approval | Zocor (simvastatin) Tablets, Merck & Co., Labeling Revision | Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Labeling Revision | Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Labeling Revision | SIMCOR (niacin extended-release/simvastatin) Tablets, Abbott Labs, Approval | Simvastatin Tablets, Accord Healthcare, Approval | Zocor (simvastatin) Tablets, Merck & Co., Inc., Labeling Revision| Vytorin (ezetimibe and simvastatin) Tablets, MSP Singapore Company, LLC, Labeling Revision | Simcor (niacin and simvastatin) Extended-Release Tablets, Abbott Laboratories, Labeling Revision
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