Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050420
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIFADIN | RIFAMPIN | 300MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 05/21/1971 | ORIG-1 | Approval | UNKNOWN |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050420Orig1s083, 050627Orig1s025ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/08/2023 | SUPPL-91 | Labeling-Patient 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-90 | 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-89 | 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-88 | Labeling-Package Insert |
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-87 | 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-86 | 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-85 | Labeling-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-84 | 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-83 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s083,050627s025lbl.pdf | |
| 02/28/2019 | SUPPL-80 | 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-78 | 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-77 | 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-76 | 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 |
| 02/27/2013 | SUPPL-75 | 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-73 | 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-72 | 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-71 | Labeling |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-70 | Labeling |
Label is not available on this site. |
||
| 09/05/1995 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1996 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 07/12/1994 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/1996 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/1993 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 10/20/1981 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1981 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 09/11/1982 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1980 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1980 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1979 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1979 | SUPPL-55 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/25/1979 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 05/01/1979 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 04/16/1979 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 04/16/1979 | SUPPL-51 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/23/1979 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 06/26/1979 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 06/29/1978 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 05/30/1978 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 02/10/1978 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 06/29/1977 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 12/21/1976 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 08/09/1976 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/1976 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1976 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/1976 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 01/28/1976 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 01/19/1976 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 03/29/1976 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 08/28/1975 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/15/1975 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/16/1975 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 01/30/1975 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 11/26/1974 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 05/21/1974 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 05/29/1974 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 03/28/1974 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1974 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 01/24/1974 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/11/1973 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/20/1973 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 05/09/1973 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1973 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/05/1972 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/25/1972 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/31/1972 | SUPPL-20 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/16/1972 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1982 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 01/26/1972 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/06/1971 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/1971 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/16/1987 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1989 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/1984 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/18/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1984 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/12/1990 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/02/1983 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/12/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/25/1977 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/17/1982 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/1982 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/05/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/08/2023 | SUPPL-91 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s091,050627s036lbl.pdf | |
| 08/16/2023 | SUPPL-90 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s090,050627s035lbl.pdf | |
| 02/17/2023 | SUPPL-89 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s089,050627s034lbl.pdf | |
| 02/10/2023 | SUPPL-88 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s088,050627s033lbl.pdf | |
| 01/29/2022 | SUPPL-87 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050420s087,050627s030lbl.pdf | |
| 10/21/2021 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050420s086,050627s029lbl.pdf | |
| 06/17/2021 | SUPPL-85 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050420s085,050627s028lbl.pdf | |
| 05/12/2020 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050420s084,050627s027lbl.pdf | |
| 08/27/2019 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s083,050627s025lbl.pdf | |
| 02/28/2019 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s080,050627s023lbl.pdf | |
| 01/23/2019 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s078,050627s021lbl.pdf | |
| 01/08/2018 | SUPPL-77 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050420s077,050627s020lbl.pdf | |
| 04/24/2017 | SUPPL-76 | 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-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.pdf | |
| 11/10/2010 | SUPPL-73 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.pdf | |
| 08/20/2004 | SUPPL-72 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50420s072,50627s008lbl.pdf |