Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074366
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2% | CREAM;VAGINAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/22/1996 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/22/2013 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/14/2001 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |