Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073507
Company: P AND L
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICONAZOLE NITRATE MICONAZOLE NITRATE 100MG SUPPOSITORY;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
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
04/22/2005 SUPPL-16 Labeling

Label is not available on this site.

02/20/2004 SUPPL-15 Labeling

Label is not available on this site.

11/21/2002 SUPPL-14 Labeling

Label is not available on this site.

01/08/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

08/30/2000 SUPPL-11 Labeling

Label is not available on this site.

04/07/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/06/1998 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-5 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

07/24/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/30/1995 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

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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