Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018888
Company: MEDTECH PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MONISTAT 3 MICONAZOLE NITRATE 200MG SUPPOSITORY;VAGINAL Prescription AB 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
08/15/1984 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
02/27/2014 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/11/2014 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/10/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/07/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/12/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/07/1998 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/17/1988 SUPPL-6 Labeling

Label is not available on this site.

09/17/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/25/1986 SUPPL-4 Labeling

Label is not available on this site.

06/25/1985 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

MONISTAT 3

SUPPOSITORY;VAGINAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MICONAZOLE NITRATE MICONAZOLE NITRATE 200MG SUPPOSITORY;VAGINAL Prescription No AB 073508 ACTAVIS PHARMA
MONISTAT 3 MICONAZOLE NITRATE 200MG SUPPOSITORY;VAGINAL Prescription Yes AB 018888 MEDTECH PRODUCTS

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