Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021024
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRIFTIN | RIFAPENTINE | 150MG | TABLET;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
06/22/1998 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21024.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/09/2020 | SUPPL-20 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021024Orig1s020ltr.pdf |
06/05/2020 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021024s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021024Orig1s017, s018ltr.pdf | |
06/05/2020 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021024s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021024Orig1s017, s018ltr.pdf | |
07/01/2015 | SUPPL-13 | Labeling-Container/Carton Labels |
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/2015/021024s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021024Orig1s013ltr.pdf |
08/07/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/25/2014 | SUPPL-11 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021024s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021024Orig1s011ltr.pdf | |
11/20/2014 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021024Orig1s010ltr.pdf |
07/30/2010 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021024s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021024s009ltr.pdf | |
06/01/2009 | SUPPL-8 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021024s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021024s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021024Orig1s008.pdf | |
12/12/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/20/2000 | SUPPL-5 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21024s5_Priftin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21024s5_Priftin_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21024S5_Priftin.cfm | |
09/13/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
12/10/1999 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/22/1999 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
04/21/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/05/2020 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021024s017s018lbl.pdf | |
06/05/2020 | SUPPL-17 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021024s017s018lbl.pdf | |
06/05/2020 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021024s017s018lbl.pdf | |
07/01/2015 | SUPPL-13 | Labeling-Container/Carton Labels | 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/2015/021024s013lbl.pdf |
11/25/2014 | SUPPL-11 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021024s011lbl.pdf | |
07/30/2010 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021024s009lbl.pdf | |
06/01/2009 | SUPPL-8 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021024s008lbl.pdf | |
10/20/2000 | SUPPL-5 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21024s5_Priftin_prntlbl.pdf | |
06/22/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21024lbl.pdf |