Application 090824
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADAPALENE | ADAPALENE | CREAM;TOPICAL | 0.1% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0424 | Adapalene | adapalene | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0424 | Adapalene | adapalene | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 63629-8791 | Adapalene | adapalene | Bryant Ranch Prepack | ANDA | Current |
| 63629-8791 | Adapalene | adapalene | Bryant Ranch Prepack | ANDA | Current |
| 63629-8791 | Adapalene | adapalene | Bryant Ranch Prepack | ANDA | Current |
| 68308-706 | Adapalene | adapalene | Mayne Pharma Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31500 | ORIG | 2010-07-02 |