Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018674
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METRO I.V. METRONIDAZOLE 500MG/100ML INJECTABLE;INJECTION 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
08/31/1982 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
06/22/1990 SUPPL-10 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.

01/25/1989 SUPPL-9 Labeling

Label is not available on this site.

07/08/1988 SUPPL-8 Labeling

Label is not available on this site.

02/22/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/22/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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