Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018517
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Discontinued None No No
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL 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
10/30/1981 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
12/14/2004 SUPPL-37 Labeling Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Label is not available on this site.

04/19/2004 SUPPL-36 Labeling

Label is not available on this site.

07/29/2002 SUPPL-34 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

12/23/1999 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/06/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/26/1996 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/26/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/01/1997 SUPPL-24 Labeling

Label is not available on this site.

04/29/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/31/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/30/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/30/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/16/1993 SUPPL-17 Labeling

Label is not available on this site.

11/03/1992 SUPPL-15 Labeling

Label is not available on this site.

11/03/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/09/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/09/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/09/1991 SUPPL-11 Labeling

Label is not available on this site.

02/26/1992 SUPPL-10 Labeling

Label is not available on this site.

05/10/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/10/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/10/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/10/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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