Application 080693
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 003 | HYDROCORTISONE | HYDROCORTISONE | CREAM;TOPICAL | 1% | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0168-0015 | hydrocortisone | Hydrocortisone | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0015 | hydrocortisone | Hydrocortisone | E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 21695-529 | Hydrocortisone | Hydrocortisone | Rebel Distributors Corp | ANDA | Current |
| 43063-228 | Hydrocortisone | Hydrocortisone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 49999-139 | Hydrocortisone | Hydrocortisone | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |