SIMVASTATIN
- Product NDC
- 55700-515
- 11-digit product format
- 557000515
- Labeler code
- 55700
- Product ID
- 55700-515_ef6716f0-7a82-4d7b-af57-5bb53f64e757
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2017-04-06
- 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