Application 081203
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYDROCORTISONE | HYDROCORTISONE | OINTMENT;TOPICAL | 2.5% | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0168-0146 | Hydrocortisone | Hydrocortisone | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0146 | Hydrocortisone | Hydrocortisone | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 53002-8780 | Hydrocortisone | Hydrocortisone | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-8780 | Hydrocortisone | Hydrocortisone | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 63629-8817 | Hydrocortisone | Hydrocortisone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8817 | Hydrocortisone | Hydrocortisone | Bryant Ranch Prepack | ANDA | Current |
| 68071-1581 | Hydrocortisone | Hydrocortisone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1581 | Hydrocortisone | Hydrocortisone | NuCare Pharmaceuticals,Inc. | ANDA | Current |