Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020827
Company: MEDTECH PRODUCTS
Company: MEDTECH PRODUCTS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MONISTAT 3 | MICONAZOLE NITRATE | 4% | CREAM;VAGINAL | Over-the-counter | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/28/2020 | SUPPL-31 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s073,020670Orig1s035,020827Orig1s031,021261Orig1s024,021308Orig1s030lbl.pdf | |
| 10/02/2009 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020827Orig1s014lbl.pdf | |
| 10/02/2009 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020827Orig1s014lbl.pdf | |
| 03/30/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3_prntlbl.pdf |