Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021024
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
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
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

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