Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021308
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, SUPPOSITORY;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
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
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, SUPPOSITORY;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, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter No 079114 PERRIGO R AND D
MONISTAT 1 COMBINATION PACK MICONAZOLE NITRATE 2%,1.2GM CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter Yes 021308 MEDTECH PRODUCTS

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