Application 215398
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BEXAROTENE | BEXAROTENE | GEL;TOPICAL | 1% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69238-2088 | Bexarotene | Bexarotene | Amneal Pharmaceuticals NY LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71936 | ORIG | 2022-08-26 |