Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074586
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
M-ZOLE 7 DUAL PACK MICONAZOLE NITRATE 2%,100MG CREAM, SUPPOSITORY;TOPICAL, VAGINAL Discontinued 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
07/17/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074586.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2002 SUPPL-6 Labeling

Label is not available on this site.

01/08/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/2000 SUPPL-3 Labeling

Label is not available on this site.

04/30/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/01/1998 SUPPL-1 Labeling

Label is not available on this site.

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