Simvastatin

Product NDC

55289-338

11-digit product format

552890338

Labeler code

55289

Product ID

55289-338_85c966d1-fecd-78c8-e053-2991aa0aa21b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Simvastatin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA076052

Marketing category

ANDA

Marketing start

2006-06-27

Marketing end

2019-12-31

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