Simvastatin

Product NDC

50268-713

11-digit product format

502680713

Labeler code

50268

Product ID

50268-713_6e130dfe-e90a-bc9f-e053-2991aa0a55b7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Simvastatin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

AvPAK

Application

ANDA077691

Marketing category

ANDA

Marketing start

2014-12-02

Marketing end

0000-00-00

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

2019-12-31

Current FDA listing

Historical FDA.report record