Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074444
Company: SUN PHARMA CANADA
Company: SUN PHARMA CANADA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2% | CREAM;VAGINAL | Over-the-counter | 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 |
|---|---|---|---|---|---|---|---|
| 01/13/1997 | 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 |
|---|---|---|---|---|---|
| 08/29/2025 | SUPPL-23 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/05/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/08/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/27/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/16/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
MICONAZOLE NITRATE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CREAM;VAGINAL; 2%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| MICONAZOLE 7 | MICONAZOLE NITRATE | 2% | CREAM;VAGINAL | Over-the-counter | No | 074164 | ENCUBE |
| MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2% | CREAM;VAGINAL | Over-the-counter | No | 074760 | PERRIGO |
| MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2% | CREAM;VAGINAL | Over-the-counter | No | 074444 | SUN PHARMA CANADA |
| MONISTAT 7 | MICONAZOLE NITRATE | 2% | CREAM;VAGINAL | Over-the-counter | Yes | 017450 | MEDTECH PRODUCTS |