Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079114
Company: PERRIGO R AND D
Company: PERRIGO R AND D
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT;TOPICAL, VAGINAL | Over-the-counter | None | No | No |
MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2% | CREAM; TOPICAL, VAGINAL | Over-the-counter | None | TBD | 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 |
---|---|---|---|---|---|---|---|
06/02/2010 | 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 |
---|---|---|---|---|---|
06/11/2020 | SUPPL-14 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
08/25/2017 | SUPPL-6 | Labeling-Package Insert |
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, INSERT;TOPICAL, VAGINAL; 2%,1.2GM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT;TOPICAL, VAGINAL | Over-the-counter | No | 079114 | PERRIGO R AND D |
MONISTAT 1 COMBINATION PACK | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT;TOPICAL, VAGINAL | Over-the-counter | Yes | 021308 | MEDTECH PRODUCTS |
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%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2% | CREAM; TOPICAL, VAGINAL | Over-the-counter | Unknown | 079114 | PERRIGO R AND D |