Application 040351
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCORTISONE | HYDROCORTISONE | LOTION;TOPICAL | 2.5% | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0288 | Hydrocortisone | hydrocortisone | E.FOUGERA & COMPANY A division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0288 | Hydrocortisone | hydrocortisone | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 7632 | ORIG | 2000-07-25 |