Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)
Zydus Lifesciences Limited
SIMVASTATIN
SIMVASTATIN 5 mg
ORAL
PRESCRIPTION DRUG
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet. In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets are indicated to: - Reduce the risk of total mortality by reducing CHD deaths. - Reduce the risk of non-fatal myocardial infarction and stroke. - Reduce the need for coronary and non-coronary revascularization procedures. Simvastatin tablets are indicated to: - Reduce elevated total cholesterol (to
Simvastatin Tablets USP, 5 mg are white, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA19" on one side and plain on other side and are supplied as follows. NDC 65841-065-06 in bottle of 30 with child-resistant closure NDC 65841-065-14 in bottle of 60 with child-resistant closure NDC 65841-065-16 in bottle of 90 with child-resistant closure NDC 65841-065-05 in bottle of 500 NDC 65841-065-10 in bottle of 1000 Simvastatin Tablets USP, 10 mg are pink, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA20" on one side and plain on other side and are supplied as follows. NDC 65841-066-06 in bottle of 30 with child-resistant closure NDC 65841-066-14 in bottle of 60 with child-resistant closure NDC 65841-066-16 in bottle of 90 with child-resistant closure NDC 65841-066-05 in bottle of 500 NDC 65841-066-10 in bottle of 1000 NDC 65841-066-24 in bottle of 10000 Simvastatin Tablets USP, 20 mg are brown, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA21" on one side and plain on other side and are supplied as follows. NDC 65841-067-06 in bottle of 30 with child-resistant closure NDC 65841-067-14 in bottle of 60 with child-resistant closure NDC 65841-067-16 in bottle of 90 with child-resistant closure NDC 65841-067-05 in bottle of 500 NDC 65841-067-10 in bottle of 1000 NDC 65841-067-24 in bottle of 10000 Simvastatin Tablets USP, 40 mg are pink, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA22" on one side and plain on other side and are supplied as follows. NDC 65841-068-06 in bottle of 30 with child-resistant closure NDC 65841-068-14 in bottle of 60 with child-resistant closure NDC 65841-068-16 in bottle of 90 with child-resistant closure NDC 65841-068-05 in bottle of 500 NDC 65841-068-10 in bottle of 1000 NDC 65841-068-40 in bottle of 5000 Simvastatin Tablets USP, 80 mg are white to off-white, capsule shaped, biconvex, film-coated tablets debossed with "ZA23" on one side and plain on other side and are supplied as follows. NDC 65841-069-06 in bottle of 30 with child-resistant closure NDC 65841-069-14 in bottle of 60 with child-resistant closure NDC 65841-069-16 in bottle of 90 with child-resistant closure NDC 65841-069-05 in bottle of 500 NDC 65841-069-10 in bottle of 1000
Abbreviated New Drug Application
SIMVASTATIN - SIMVASTATIN TABLET, FILM COATED ZYDUS LIFESCIENCES LIMITED ---------- SIMVASTATIN TABLETS PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-065-16 in bottle of 90 tablets Simvastatin Tablets USP, 5 mg Rx only NDC 65841-066-16 in bottle of 90 tablets Simvastatin Tablets USP, 10 mg Rx only NDC 65841-067-16 in bottle of 90 tablets Simvastatin Tablets USP, 20 mg Rx only NDC 65841-068-16 in bottle of 90 tablets Simvastatin Tablets USP, 40 mg Rx only NDC 65841-069-16 in bottle of 90 tablets Simvastatin Tablets USP, 80 mg Rx only SIMVASTATIN simvastatin tablet, film coated PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:65841-065 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) SIMVASTATIN 5 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) ASCORBIC ACID (UNII: PQ6CK8PD0R) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PRODUCT CHARACTERISTICS COLOR WHITE (WHITE) SCORE no score SHAPE OVAL (OVAL) SIZE 9mm FLAVOR IMPRINT CODE Z A19 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:65841-065- 06 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/20/2006 2 NDC:65841-065- 14 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/20/2006 3 NDC:65841-065- 16 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/20/2006 4 NDC:65841-065- 05 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/20/2006 5 NDC:65841-065- 10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/20/2006 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA077837 12/20/2006 SIMVASTATIN simvastatin tablet, film coat Aqra d-dokument sħiħ