Application 077197
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METRONIDAZOLE | METRONIDAZOLE | LOTION;TOPICAL | 0.75% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0383 | Metronidazole | Metronidazole | Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0383 | Metronidazole | Metronidazole | Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0383 | Metronidazole | Metronidazole | E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9017 | ORIG | 2006-05-25 |