Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018674
Company: B BRAUN
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. |
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01/25/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/08/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
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02/22/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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02/22/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |