Application 021735
- Type
- NDA
- Sponsor
- FOUGERA PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TERCONAZOLE | TERCONAZOLE | CREAM;VAGINAL | 0.8% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0168-0347 | Terconazole | terconazole | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 0168-0347 | Terconazole | terconazole | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 63629-8837 | Terconazole | terconazole | Bryant Ranch Prepack | NDA | Current |
| 63629-8837 | Terconazole | terconazole | Bryant Ranch Prepack | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83194 | SUPPL | 2025-08-26 |
| 83180 | SUPPL | 2025-08-25 |
| 28494 | SUPPL | 2011-01-05 |
| 37557 | SUPPL | 2011-01-04 |
| 21799 | ORIG | 2006-07-27 |
| 16282 | ORIG | 2004-10-05 |
| 6086 | ORIG | 2004-10-05 |