Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021261
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
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-Package Insert, Labeling-Container/Carton Labels 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021261Orig1s009lbl.pdf
12/21/2009 SUPPL-9 Labeling-Container/Carton Labels 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

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