Application 074414
- Type
- ANDA
- Sponsor
- ACP NIMBLE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MICONAZOLE NITRATE | MICONAZOLE NITRATE | SUPPOSITORY;VAGINAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0713-0197 | Miconazole Nitrate | Miconazole Nitrate | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-0197 | Miconazole Nitrate | Miconazole Nitrate | G&W Laboratories, Inc. | ANDA | Current |
| 42254-295 | Miconazole Nitrate | Miconazole Nitrate | Rebel Distributors Corp | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42845 | ORIG | 2005-07-22 |