Application 077001
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HALOBETASOL PROPIONATE | HALOBETASOL PROPIONATE | CREAM;TOPICAL | 0.05% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0355 | Halobetasol Propionate | halobetasol propionate | Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0355 | Halobetasol Propionate | halobetasol propionate | E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0355 | Halobetasol Propionate | halobetasol propionate | Fougera Pharmaceuticals Inc. | ANDA | Current |
| 63629-8735 | Halobetasol Propionate | halobetasol propionate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8735 | Halobetasol Propionate | halobetasol propionate | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8990 | ORIG | 2004-12-30 |