Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017450
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
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
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 074366 COSETTE
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 PHARMS
MONISTAT 7 MICONAZOLE NITRATE 2% CREAM;VAGINAL Over-the-counter Yes 017450 MEDTECH PRODUCTS

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