Application 021789
- Type
- NDA
- Sponsor
- GALDERMA LABS LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METROGEL | METRONIDAZOLE | GEL;TOPICAL | 1% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0299-3820 | METROGEL | metronidazole | Galderma Laboratories, L.P. | NDA | Current |
| 0299-3820 | METROGEL | metronidazole | Galderma Laboratories, L.P. | NDA | Current |
| 0299-3820 | METROGEL | metronidazole | Galderma Laboratories, L.P. | NDA | Current |
| 0299-3820 | METROGEL | metronidazole | Galderma Laboratories, L.P. | NDA | Current |
| 51672-5295 | metronidazole | metronidazole | Taro Pharmaceuticals U.S.A., Inc. | NDA AUTHORIZED GENERIC | Current |
| 66993-936 | metronidazole | metronidazole | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-936 | metronidazole | metronidazole | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76663 | SUPPL | 2023-11-24 |
| 76662 | SUPPL | 2023-11-24 |
| 70545 | SUPPL | 2022-03-17 |
| 70544 | SUPPL | 2022-03-17 |
| 70537 | SUPPL | 2022-03-17 |
| 70536 | SUPPL | 2022-03-17 |
| 42312 | SUPPL | 2012-10-12 |
| 16375 | SUPPL | 2011-11-04 |
| 6190 | SUPPL | 2011-10-24 |
| 16374 | SUPPL | 2010-03-17 |
| 28606 | SUPPL | 2010-03-09 |
| 42311 | ORIG | 2006-09-26 |
| 16373 | SUPPL | 2005-11-18 |
| 6189 | SUPPL | 2005-11-18 |
| 6188 | ORIG | 2005-07-08 |
| 37651 | ORIG | 2005-07-07 |