Application 076141
- Type
- ANDA
- Sponsor
- HI TECH PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMBELINE | CLOBETASOL PROPIONATE | GEL;TOPICAL | 0.05% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50383-269 | Clobetasol Propionate | Clobetasol Propionate | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-269 | Clobetasol Propionate | Clobetasol Propionate | Akorn | ANDA | Current |
| 50383-269 | Clobetasol Propionate | Clobetasol Propionate | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8869 | ORIG | 2003-04-10 |