Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018818
Company: MUTUAL PHARM
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
02/16/1983 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
12/01/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/21/1997 SUPPL-31 Labeling

Label is not available on this site.

12/23/1994 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/18/1991 SUPPL-22 Labeling

Label is not available on this site.

06/07/1991 SUPPL-21 Labeling

Label is not available on this site.

05/08/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/08/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/01/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/01/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/29/1988 SUPPL-16 Labeling

Label is not available on this site.

04/03/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/13/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/13/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/13/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/31/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/02/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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