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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021024
Company: SANOFI AVENTIS US

Medication Guide

Products on NDA 021024

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRIFTIN	RIFAPENTINE	150MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021024

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.

Labels for NDA 021024

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

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