FDA Approval for RIFADIN issued to SANOFI AVENTIS US
$SNY
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 050627
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIFADIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/25/1989 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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-37 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050420s092,050627s037lbl.pdf | ||
| 12/08/2023 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s091,050627s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050420Orig1s091; 050627Orig1s036ltr.pdf | |
| 08/16/2023 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s090,050627s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050420Orig1s090;050627Orig1s035ltr.pdf | |
| 02/17/2023 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s089,050627s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050420Orig1s089;050627Orig1s034ltr.pdf | |
| 02/10/2023 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s088,050627s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050420Orig1s088;050627Orig1s033ltr.pdf | |
| 01/29/2022 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050420s087,050627s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050420Orig1s087; 050627Orig1s030ltr.pdf | |
| 10/21/2021 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050420s086,050627s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050420Orig1s086,050627Orig1s029ltr.pdf | |
| 06/17/2021 | SUPPL-28 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050420s085,050627s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050420Orig1s085; 050627Orig1s028ltr.pdf | |
| 05/12/2020 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050420s084,050627s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050420Orig1s084,050627Orig1s027ltr.pdf | |
| 08/27/2019 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s083,050627s025lbl.pdf | |
| 02/28/2019 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s080,050627s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050420Orig1s080, 050627Orig1s023ltr.pdf | |
| 01/23/2019 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s078,050627s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050420Orig1s078, 050627Orig1s021ltr.pdf | |
| 01/08/2018 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050420s077,050627s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050420Orig1s077, 050627Orig1s020ltr.pdf | |
| 04/24/2017 | SUPPL-17 | 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/2017/050420s076,050627s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050627Orig1S017,050420Orig1S076ltr.pdf |
| 12/02/2015 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2013 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050420Orig1s075,050627Orig1s014ltr.pdf | |
| 11/10/2010 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050420s073,050627s012ltr.pdf | |
| 08/20/2004 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50420s072,50627s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50420s072,50627s008ltr.pdf | |
| 04/12/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/28/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/10/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/18/1993 | 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-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050420s092,050627s037lbl.pdf | |
| 12/08/2023 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s091,050627s036lbl.pdf | |
| 08/16/2023 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s090,050627s035lbl.pdf | |
| 02/17/2023 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s089,050627s034lbl.pdf | |
| 02/10/2023 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s088,050627s033lbl.pdf | |
| 01/29/2022 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050420s087,050627s030lbl.pdf | |
| 10/21/2021 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050420s086,050627s029lbl.pdf | |
| 06/17/2021 | SUPPL-28 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050420s085,050627s028lbl.pdf | |
| 05/12/2020 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050420s084,050627s027lbl.pdf | |
| 08/27/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s083,050627s025lbl.pdf | |
| 02/28/2019 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s080,050627s023lbl.pdf | |
| 01/23/2019 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s078,050627s021lbl.pdf | |
| 01/08/2018 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050420s077,050627s020lbl.pdf | |
| 04/24/2017 | SUPPL-17 | 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/2017/050420s076,050627s017lbl.pdf |
| 02/27/2013 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.pdf | |
| 11/10/2010 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.pdf | |
| 08/20/2004 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50420s072,50627s008lbl.pdf |
RIFADIN
INJECTABLE;INJECTION; 600MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RIFADIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050627 | SANOFI AVENTIS US |
| RIFAMPIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065502 | EPIC PHARMA LLC |
| RIFAMPIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091181 | FRESENIUS KABI USA |
| RIFAMPIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064217 | HIKMA |
| RIFAMPIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205039 | HIKMA PHARMS |
| RIFAMPIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065421 | MYLAN LABS LTD |