New Drug Application (NDA): 050705
Company: SANOFI AVENTIS US

Products on NDA 050705

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIFATER	ISONIAZID; PYRAZINAMIDE; RIFAMPIN	50MG;300MG;120MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050705

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/1994	ORIG-1	Approval	Type 4 - New Combination	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-26		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050705s026lbl.pdf
12/08/2023	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050705s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050705Orig1s024ltr.pdf
08/16/2023	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050705s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050705Orig1s023ltr.pdf
02/10/2023	SUPPL-22	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050705s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050705Orig1s022ltr.pdf
01/29/2022	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050705s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050705Orig1s021ltr.pdf
10/21/2021	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050705s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050705Orig1s020ltr.pdf
06/17/2021	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050705s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050705Orig1s019ltr.pdf
05/12/2020	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050705s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050705Orig1s018ltr.pdf
08/27/2019	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050705Orig1s017ltr.pdf
02/28/2019	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050705Orig1s015ltr.pdf
01/23/2019	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050705Orig1s013ltr.pdf
01/08/2018	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050705s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050705Orig1s012ltr.pdf
04/24/2017	SUPPL-11	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/2017/050705s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050705Orig1s011ltr.pdf
02/27/2013	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050705s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050705Orig1s010ltr.pdf
11/12/2010	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050705s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050705s007ltr.pdf
12/18/2008	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050705s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050705s006ltr.pdf
04/28/2005	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050705s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050705s005ltr.pdf
10/06/2000	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/12/2000	SUPPL-3	Labeling		Label is not available on this site.
04/08/1996	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
07/08/1994	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 050705

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2024	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050705s026lbl.pdf
12/08/2023	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050705s024lbl.pdf
08/16/2023	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050705s023lbl.pdf
02/10/2023	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050705s022lbl.pdf
01/29/2022	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050705s021lbl.pdf
10/21/2021	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050705s020lbl.pdf
06/17/2021	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050705s019lbl.pdf
05/12/2020	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050705s018lbl.pdf
08/27/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s017lbl.pdf
02/28/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s015lbl.pdf
01/23/2019	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s013lbl.pdf
01/08/2018	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050705s012lbl.pdf
04/24/2017	SUPPL-11	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/2017/050705s011lbl.pdf
02/27/2013	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050705s010lbl.pdf
11/12/2010	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050705s007lbl.pdf
12/18/2008	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050705s006lbl.pdf
04/28/2005	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050705s005lbl.pdf

FDA Approval for RIFATER issued to SANOFI AVENTIS US