Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074760
Company: PERRIGO
Company: PERRIGO
| 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 |
|---|---|---|---|---|---|---|---|
| 05/15/1997 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074760.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/21/2017 | SUPPL-37 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/14/2005 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/17/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/30/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/30/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/08/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-2 | 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 | P AND L |
| 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 | TARO |
| MONISTAT 7 | MICONAZOLE NITRATE | 2% | CREAM;VAGINAL | Over-the-counter | Yes | 017450 | MEDTECH PRODUCTS |