Abiraterone acetate
- Product NDC
- 57894-199
- 11-digit product format
- 578940199
- Labeler code
- 57894
- Product ID
- 57894-199_8bafd33c-67e4-11e9-b7f0-46bf0099106d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone acetate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Janssen Biotech, Inc.
- Application
- NDA202379
- Marketing category
- NDA
- Marketing start
- 2018-03-05
- Marketing end
- 0000-00-00
- Substance
- ABIRATERONE ACETATE
- Active strength
- 500 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record