Application 208416
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ABIRATERONE ACETATE | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No |
| 002 | ABIRATERONE ACETATE | ABIRATERONE ACETATE | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-963 | Abiraterone Acetate | Abiraterone Acetate | NorthStar Rx LLC | ANDA | Current |
| 16714-963 | Abiraterone Acetate | Abiraterone Acetate | NorthStar Rx LLC | ANDA | Current |
| 16714-963 | Abiraterone Acetate | Abiraterone Acetate | NorthStar Rx LLC | ANDA | Current |
| 43598-358 | Abiraterone Acetate | Abiraterone Acetate | Dr. Reddys Laboratories Inc | ANDA | Current |
| 43598-358 | Abiraterone Acetate | Abiraterone Acetate | Dr. Reddys Laboratories Inc | ANDA | Current |
| 43598-358 | Abiraterone Acetate | Abiraterone Acetate | Dr. Reddys Laboratories Inc | ANDA | Current |
| 43598-358 | Abiraterone Acetate | Abiraterone Acetate | Dr. Reddys Laboratories Inc | ANDA | Current |
| 43598-358 | Abiraterone Acetate | Abiraterone Acetate | Dr. Reddys Laboratories Inc | ANDA | Current |