Abiraterone Acetate
- Product NDC
- 0378-6924
- 11-digit product format
- 003786924
- Labeler code
- 0378
- Product ID
- 0378-6924_16cd9ff7-86d7-49ab-8579-7be174844486
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- abiraterone acetate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA208446
- Marketing category
- ANDA
- Marketing start
- 2018-11-21
- Marketing end
- 0000-00-00
- Substance
- ABIRATERONE ACETATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record