Application 021308
- Type
- NDA
- Sponsor
- MEDTECH PRODUCTS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MONISTAT 1 COMBINATION PACK | MICONAZOLE NITRATE | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 2%,1.2GM | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-5201 | Miconazole 1 | Miconazole Nitrate | WALGREEN COMPANY | NDA | Current |
| 63736-001 | Monistat 1 Combination Pack | Miconazole Nitrate | Insight Pharmaceuticals | NDA | Current |
| 63736-013 | Monistat 1 Combination Pack | Miconazole Nitrate | Insight Pharmaceuticals | NDA | Current |
| 63736-013 | Monistat 1 Combination Pack | Miconazole Nitrate | Insight Pharmaceuticals LLC | NDA | Current |
| 63736-014 | Monistat 1 Combination Pack | Miconazole Nitrate | Insight Pharmaceuticals | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 70549 | SUPPL | 2022-03-17 |
| 70399 | SUPPL | 2022-03-04 |
| 61731 | SUPPL | 2020-01-29 |
| 61730 | SUPPL | 2020-01-29 |
| 49512 | SUPPL | 2017-08-22 |
| 21590 | SUPPL | 2007-11-19 |
| 27449 | SUPPL | 2005-04-06 |
| 36632 | SUPPL | 2004-10-05 |
| 27448 | SUPPL | 2004-10-05 |
| 27447 | SUPPL | 2004-06-09 |
| 27446 | ORIG | 2004-06-09 |
| 21589 | ORIG | 2004-06-09 |
| 4996 | SUPPL | 2004-06-09 |
| 4997 | SUPPL | 2003-12-08 |
| 15162 | ORIG | 2003-05-07 |