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. |
||
| 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. |
||
| 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. |
||
| 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. |