Drugs@FDA: FDA-Approved Drugs
Company: MEDTECH PRODUCTS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MONISTAT 7 | MICONAZOLE NITRATE | 2% | 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 |
|---|---|---|---|---|---|---|---|
| 01/30/1974 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/22/2020 | SUPPL-75 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s075,020670Orig1s036,021261Orig1s025,021308Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/17450Orig1s075,20670Orig1s036,21261Orig1s025,21308Orig1s031ltr.pdf | |
| 01/28/2020 | SUPPL-73 | 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 | |
| 08/10/2015 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/2014 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2014 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/2013 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/2013 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/2013 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/2009 | SUPPL-56 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017450Orig1s056lbl.pdf | |
| 08/21/2008 | SUPPL-55 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017450Orig1s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017450s055ltr.pdf | |
| 08/07/2002 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17450s52lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17450scp052ltr.pdf | |
| 10/28/2002 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/2002 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/16/2001 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1999 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1999 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/03/1999 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/17/1998 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1997 | SUPPL-43 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/06/1995 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/03/1993 | SUPPL-41 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/09/1995 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 10/08/1992 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 04/26/1993 | SUPPL-38 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/03/1992 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-35 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
||
| 03/09/1990 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1986 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1986 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/22/1986 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/1985 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/27/1985 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1984 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1984 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1983 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1982 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 05/13/1982 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1982 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/19/1982 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1982 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/03/1980 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1979 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1979 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1979 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1979 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1978 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/23/1979 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1978 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1977 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1977 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1977 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/28/1977 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/1976 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/22/2020 | SUPPL-75 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s075,020670Orig1s036,021261Orig1s025,021308Orig1s031lbl.pdf | |
| 01/28/2020 | SUPPL-73 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s073,020670Orig1s035,020827Orig1s031,021261Orig1s024,021308Orig1s030lbl.pdf | |
| 11/05/2009 | SUPPL-56 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017450Orig1s056lbl.pdf | |
| 11/05/2009 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017450Orig1s056lbl.pdf | |
| 08/21/2008 | SUPPL-55 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017450Orig1s055lbl.pdf |
| 08/07/2002 | SUPPL-52 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17450s52lbl.pdf |
MONISTAT 7
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CREAM;VAGINAL; 2%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| MICONAZOLE 7 | MICONAZOLE NITRATE | 2% | CREAM;VAGINAL | Over-the-counter | No | 074164 | P AND L |
| MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2% | CREAM;VAGINAL | Over-the-counter | No | 074760 | PERRIGO |
| MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2% | CREAM;VAGINAL | Over-the-counter | No | 074444 | TARO |
| MONISTAT 7 | MICONAZOLE NITRATE | 2% | CREAM;VAGINAL | Over-the-counter | Yes | 017450 | MEDTECH PRODUCTS |