Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021261
Company: MEDTECH PRODUCTS
Company: MEDTECH PRODUCTS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MONISTAT 3 COMBINATION PACK | MICONAZOLE NITRATE | 2%,4% | CREAM;TOPICAL, VAGINAL | Over-the-counter | None | Yes | No |
| MONISTAT 3 COMBINATION PACK (PREFILLED) | MICONAZOLE NITRATE | 2%,4% | CREAM;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 |
|---|---|---|---|---|---|---|---|
| 02/02/2001 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21261lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-261_Monistat%203_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-261_Monistat3.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/22/2020 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/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-24 | 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-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2014 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/2014 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/2013 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/2009 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021261Orig1s009lbl.pdf | |
| 10/28/2008 | SUPPL-7 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021261s007ltr.pdf |
| 06/17/2003 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21261slr004ltr.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. |
||
| 11/28/2001 | 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 |
|---|---|---|---|---|---|
| 07/22/2020 | SUPPL-25 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s075,020670Orig1s036,021261Orig1s025,021308Orig1s031lbl.pdf | |
| 01/28/2020 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s073,020670Orig1s035,020827Orig1s031,021261Orig1s024,021308Orig1s030lbl.pdf | |
| 12/21/2009 | SUPPL-9 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021261Orig1s009lbl.pdf | |
| 12/21/2009 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021261Orig1s009lbl.pdf | |
| 02/02/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21261lbl.pdf |
MONISTAT 3 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;TOPICAL, VAGINAL; 2%,4%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| MICONAZOLE 3 COMBINATION PACK | MICONAZOLE NITRATE | 2%,4% | CREAM;TOPICAL, VAGINAL | Over-the-counter | No | 076357 | PERRIGO |
| MONISTAT 3 COMBINATION PACK | MICONAZOLE NITRATE | 2%,4% | CREAM;TOPICAL, VAGINAL | Over-the-counter | Yes | 021261 | MEDTECH PRODUCTS |
| MONISTAT 3 COMBINATION PACK (PREFILLED) | MICONAZOLE NITRATE | 2%,4% | CREAM;TOPICAL, VAGINAL | Over-the-counter | Yes | 021261 | MEDTECH PRODUCTS |
MONISTAT 3 COMBINATION PACK (PREFILLED)
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CREAM;TOPICAL, VAGINAL; 2%,4%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| MICONAZOLE 3 COMBINATION PACK | MICONAZOLE NITRATE | 2%,4% | CREAM;TOPICAL, VAGINAL | Over-the-counter | No | 076357 | PERRIGO |
| MONISTAT 3 COMBINATION PACK | MICONAZOLE NITRATE | 2%,4% | CREAM;TOPICAL, VAGINAL | Over-the-counter | Yes | 021261 | MEDTECH PRODUCTS |
| MONISTAT 3 COMBINATION PACK (PREFILLED) | MICONAZOLE NITRATE | 2%,4% | CREAM;TOPICAL, VAGINAL | Over-the-counter | Yes | 021261 | MEDTECH PRODUCTS |