Application 074366
- Type
- ANDA
- Sponsor
- ACP NIMBLE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MICONAZOLE NITRATE | MICONAZOLE NITRATE | CREAM;VAGINAL | 2% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0713-0252 | Miconazole Nitrate | Miconazole Nitrate | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-0252 | Miconazole Nitrate | Miconazole Nitrate | G&W Laboratories, Inc. | ANDA | Current |
| 50090-0462 | Miconazole Nitrate | Miconazole Nitrate | A-S Medication Solutions | ANDA | Current |
| 70518-0811 | Miconazole Nitrate | Miconazole Nitrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0811 | Miconazole Nitrate | Miconazole Nitrate | REMEDYREPACK INC. | ANDA | Current |
| 76413-318 | Miconazole Nitrate | Miconazole Nitrate | Central Texas Community Health Centers | ANDA | Current |