Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076357
Company: PERRIGO
Company: PERRIGO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MICONAZOLE 3 COMBINATION PACK | MICONAZOLE NITRATE | 2%,4% | CREAM;TOPICAL, 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 |
---|---|---|---|---|---|---|---|
03/30/2004 | 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 |
---|---|---|---|---|---|
08/21/2017 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
04/12/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
MICONAZOLE 3 COMBINATION PACK
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CREAM;TOPICAL, VAGINAL; 2%,4%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
MICONAZOLE 3 COMBINATION PACK | MICONAZOLE NITRATE | 2%,4% | CREAM;TOPICAL, VAGINAL | Over-the-counter | No | 076357 | PERRIGO |
MONISTAT 3 COMBINATION PACK | MICONAZOLE NITRATE | 2%,4% | CREAM;TOPICAL, VAGINAL | Over-the-counter | Yes | 021261 | MEDTECH PRODUCTS |
MONISTAT 3 COMBINATION PACK (PREFILLED) | MICONAZOLE NITRATE | 2%,4% | CREAM;TOPICAL, VAGINAL | Over-the-counter | Yes | 021261 | MEDTECH PRODUCTS |