Simvastatin

Product NDC

0904-5800

11-digit product format

009045800

Labeler code

0904

Product ID

0904-5800_7309e48c-6bd1-4535-94d2-f897a8585d0b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Simvastatin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Major Pharmaceuticals

Application

ANDA077752

Marketing category

ANDA

Marketing start

2006-12-20

Marketing end

2019-04-25

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