Simvastatin

Product NDC

51079-454

11-digit product format

510790454

Labeler code

51079

Product ID

51079-454_9af1b4b7-abf7-2bc7-e053-2a95a90a6153

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Simvastatin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA076052

Marketing category

ANDA

Marketing start

2006-07-10

Marketing end

2020-04-30

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