Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018520
Company: MEDTECH PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MONISTAT 7 MICONAZOLE NITRATE 100MG SUPPOSITORY;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
03/15/1982 ORIG-1 Approval Type 3 - New Dosage Form 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
07/10/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/26/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/17/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/08/1992 SUPPL-14 Labeling

Label is not available on this site.

06/03/1992 SUPPL-12 Labeling

Label is not available on this site.

02/15/1991 SUPPL-11 Efficacy-Rx To OTC Switch

Label is not available on this site.

09/11/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/04/1985 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/24/1985 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/27/1983 SUPPL-5 Labeling

Label is not available on this site.

06/02/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/20/1982 SUPPL-3 Labeling

Label is not available on this site.

05/13/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/19/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

MONISTAT 7

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SUPPOSITORY;VAGINAL; 100MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MICONAZOLE NITRATE MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter No 074414 COSETTE
MICONAZOLE NITRATE MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter No 073507 P AND L
MICONAZOLE NITRATE MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter No 074395 PERRIGO
MONISTAT 7 MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter Yes 018520 MEDTECH PRODUCTS

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