Application 080692
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCORTISONE | HYDROCORTISONE | OINTMENT;TOPICAL | 1% | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0020 | Hydrocortisone | Hydrocortisone | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0020 | Hydrocortisone | Hydrocortisone | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 53002-8350 | Hydrocortisone | Hydrocortisone | RPK Pharmaceuticals, Inc. | ANDA | Current |