New Drug Application (NDA): 050420
Company: SANOFI AVENTIS US

Products on NDA 050420

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIFADIN	RIFAMPIN	300MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050420

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
10/10/2024	SUPPL-92		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050420s092,050627s037lbl.pdf
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.

Labels for NDA 050420

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2024	SUPPL-92	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050420s092,050627s037lbl.pdf
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

FDA Approval for RIFADIN issued to SANOFI AVENTIS US