Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074366
Company: COSETTE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICONAZOLE NITRATE MICONAZOLE NITRATE 2% CREAM;VAGINAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/22/1996 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/22/2013 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

12/13/2002 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/14/2001 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/24/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/25/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

MICONAZOLE NITRATE

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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