SIMVASTATIN tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)

Tilgjengelig fra:

Zydus Lifesciences Limited

INN (International Name):

SIMVASTATIN

Sammensetning:

SIMVASTATIN 5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

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