Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073508
Company: ACTAVIS PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICONAZOLE NITRATE MICONAZOLE NITRATE 200MG SUPPOSITORY;VAGINAL Prescription AB 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
11/19/1993 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
07/09/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/24/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/28/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/11/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/24/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/24/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/24/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/15/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/30/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

MICONAZOLE NITRATE

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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