Simvastatin

Product NDC

0093-7153

11-digit product format

000937153

Labeler code

0093

Product ID

0093-7153_68c57a69-a821-44fb-a778-a91e2c1c5f5c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Simvastatin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Teva Pharmaceuticals USA, Inc.

Application

ANDA076052

Marketing category

ANDA

Marketing start

2006-06-27

Marketing end

2020-08-31

Substance

SIMVASTATIN

Active strength

10 mg/1

Pharmacologic classes

HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record