FDA Approval for RIFATER issued to SANOFI AVENTIS US
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 050705
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIFATER | ISONIAZID; PYRAZINAMIDE; RIFAMPIN | 50MG;300MG;120MG | TABLET;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/31/1994 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/10/2024 | SUPPL-26 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050705s026lbl.pdf | ||
| 12/08/2023 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050705s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050705Orig1s024ltr.pdf | |
| 08/16/2023 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050705s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050705Orig1s023ltr.pdf | |
| 02/10/2023 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050705s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050705Orig1s022ltr.pdf | |
| 01/29/2022 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050705s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050705Orig1s021ltr.pdf | |
| 10/21/2021 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050705s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050705Orig1s020ltr.pdf | |
| 06/17/2021 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050705s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050705Orig1s019ltr.pdf | |
| 05/12/2020 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050705s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050705Orig1s018ltr.pdf | |
| 08/27/2019 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050705Orig1s017ltr.pdf | |
| 02/28/2019 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050705Orig1s015ltr.pdf | |
| 01/23/2019 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050705Orig1s013ltr.pdf | |
| 01/08/2018 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050705s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050705Orig1s012ltr.pdf | |
| 04/24/2017 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050705s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050705Orig1s011ltr.pdf |
| 02/27/2013 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050705s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050705Orig1s010ltr.pdf | |
| 11/12/2010 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050705s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050705s007ltr.pdf | |
| 12/18/2008 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050705s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050705s006ltr.pdf | |
| 04/28/2005 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050705s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050705s005ltr.pdf | |
| 10/06/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/08/1996 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/08/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/10/2024 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050705s026lbl.pdf | |
| 12/08/2023 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050705s024lbl.pdf | |
| 08/16/2023 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050705s023lbl.pdf | |
| 02/10/2023 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050705s022lbl.pdf | |
| 01/29/2022 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050705s021lbl.pdf | |
| 10/21/2021 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050705s020lbl.pdf | |
| 06/17/2021 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050705s019lbl.pdf | |
| 05/12/2020 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050705s018lbl.pdf | |
| 08/27/2019 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s017lbl.pdf | |
| 02/28/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s015lbl.pdf | |
| 01/23/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s013lbl.pdf | |
| 01/08/2018 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050705s012lbl.pdf | |
| 04/24/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050705s011lbl.pdf |
| 02/27/2013 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050705s010lbl.pdf | |
| 11/12/2010 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050705s007lbl.pdf | |
| 12/18/2008 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050705s006lbl.pdf | |
| 04/28/2005 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050705s005lbl.pdf |