New Drug Application (NDA): 050627
Company: SANOFI AVENTIS US

Products on NDA 050627

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIFADIN	RIFAMPIN	600MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050627

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.

Labels for NDA 050627

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

Therapeutic Equivalents for NDA 050627

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

FDA Approval for RIFADIN issued to SANOFI AVENTIS US