Application 076364
- Type
- ANDA
- Sponsor
- TARO PHARM INDS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | SOLUTION;TOPICAL | 0.1% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51672-4061 | Hydrocortisone Butyrate | Hydrocortisone Butyrate | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4061 | Hydrocortisone Butyrate | Hydrocortisone Butyrate | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8901 | ORIG | 2004-01-15 |