Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018871
Company: ORTHO MCNEIL PHARM
Company: ORTHO MCNEIL PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROTOSTAT | METRONIDAZOLE | 250MG | TABLET;ORAL | Discontinued | None | No | No |
PROTOSTAT | 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 |
---|---|---|---|---|---|---|---|
03/02/1983 | 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 |
---|---|---|---|---|---|
02/11/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
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12/20/1988 | SUPPL-18 | Labeling |
Label is not available on this site. |
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07/22/1988 | SUPPL-17 | Labeling |
Label is not available on this site. |