Drugs@FDA: FDA-Approved Drugs
Company: MEDTECH PRODUCTS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MONISTAT 1 COMBINATION PACK | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT;TOPICAL, 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 |
---|---|---|---|---|---|---|---|
06/29/2001 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/021308Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21308ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-308_Monistat.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/22/2020 | SUPPL-31 | 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-30 | 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 | |
02/11/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/13/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/10/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/06/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/04/2005 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021308Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21308s010ltr.pdf | |
10/01/2004 | SUPPL-9 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021308Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21308s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021308_S009_MONISTAT 1.pdf | |
12/03/2003 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21308scp008ltr.pdf |
11/20/2002 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21308slr005ltr.pdf |
09/06/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21308scp004ltr.pdf |
10/28/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/10/2002 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/06/2002 | SUPPL-1 | Manufacturing (CMC) |
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-31 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s075,020670Orig1s036,021261Orig1s025,021308Orig1s031lbl.pdf | |
01/28/2020 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s073,020670Orig1s035,020827Orig1s031,021261Orig1s024,021308Orig1s030lbl.pdf | |
04/04/2005 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021308Orig1s010lbl.pdf | |
10/01/2004 | SUPPL-9 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021308Orig1s009lbl.pdf | |
06/29/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/021308Orig1s000lbl.pdf |
MONISTAT 1 COMBINATION PACK
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 |