Ezetimibe and Simvastatin
- Product NDC
- 0115-1387
- 11-digit product format
- 001151387
- Labeler code
- 0115
- Product ID
- 0115-1387_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
- 2020-03-31
- 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