Application 075368
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | GEL;TOPICAL | 0.05% | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0293 | Clobetasol Propionate | clobetasol propionate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0293 | Clobetasol Propionate | clobetasol propionate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0293 | Clobetasol Propionate | clobetasol propionate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8635 | ORIG | 2000-02-15 |