Ezetimibe and Simvastatin

Product NDC

0115-1385

11-digit product format

001151385

Labeler code

0115

Product ID

0115-1385_468e8135-899e-47d8-b620-23e6c208f9db

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

EZETIMIBE and SIMVASTATIN

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Impax Generics

Application

ANDA201890

Marketing category

ANDA

Marketing start

2017-04-26

Marketing end

2020-05-31

Substance

EZETIMIBE; SIMVASTATIN

Active strength

10 mg/1; mg/1

Pharmacologic classes

Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],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