Application 076654
- Type
- ANDA
- Sponsor
- TARO PHARM INDS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | CREAM;TOPICAL | 0.1% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51672-4074 | Hydrocortisone Butyrate | Hydrocortisone Butyrate | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4074 | Hydrocortisone Butyrate | Hydrocortisone Butyrate | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31152 | ORIG | 2005-08-08 |