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

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