Drugs@FDA: FDA-Approved Drugs
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/30/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/15/2021 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020827Orig1s033ltr.pdf |
01/28/2020 | SUPPL-31 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s073,020670Orig1s035,020827Orig1s031,021261Orig1s024,021308Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017450Orig1s073,020670Orig1s035,020827Orig1s031,021261Orig1s024,021308Orig1s030ltr.pdf | |
03/10/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/27/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/11/2014 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/10/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/29/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/02/2009 | SUPPL-14 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020827Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020827s014ltr.pdf | |
09/05/2008 | SUPPL-13 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020827s013ltr.pdf |
10/28/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/10/2002 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/28/2001 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/17/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/07/2002 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20827slr006ltr.pdf |
03/26/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/30/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/27/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/06/1998 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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 |
MONISTAT 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 |