Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062303
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIFADIN | RIFAMPIN | 150MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
07/15/1981 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/23/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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08/18/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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10/23/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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07/24/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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07/24/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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09/28/1995 | SUPPL-1 | 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. |