Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061884
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIFAMATE | ISONIAZID; RIFAMPIN | 150MG;300MG | 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 |
---|---|---|---|---|---|---|---|
07/11/1975 | 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 |
---|---|---|---|---|---|
09/27/2019 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2019 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2019 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2019 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2019 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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07/22/2013 | SUPPL-17 | Labeling |
Label is not available on this site. |
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07/22/2013 | SUPPL-15 | Labeling |
Label is not available on this site. |
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08/19/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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08/27/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
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12/09/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |