Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076773
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MICONAZOLE 3 | MICONAZOLE NITRATE | 4% | 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 |
---|---|---|---|---|---|---|---|
03/02/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076773ltr.pdf |
MICONAZOLE 3
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CREAM;VAGINAL; 4%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
MICONAZOLE 3 | MICONAZOLE NITRATE | 4% | CREAM;VAGINAL | Over-the-counter | No | 076773 | TARO |
MICONAZOLE NITRATE | MICONAZOLE NITRATE | 4% | CREAM;VAGINAL | Over-the-counter | No | 091366 | PERRIGO R AND D |
MONISTAT 3 | MICONAZOLE NITRATE | 4% | CREAM;VAGINAL | Over-the-counter | Yes | 020827 | MEDTECH PRODUCTS |