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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210455
Company: JANSSEN PRODS

Products on NDA 210455

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYMTUZA	COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	150MG;800MG;200MG;EQ 10MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210455

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/17/2018	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210455s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210455Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210455Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2023	SUPPL-23	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210455s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210455Orig1s023ltr.pdf
10/20/2022	SUPPL-22	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210455s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210455Orig1s022ltr.pdf
04/14/2022	SUPPL-20	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210455s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210455Orig1s020ltr.pdf
06/28/2021	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210455s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210455Orig1s017ltr.pdf
07/29/2021	SUPPL-16	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210455s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210455Orig1s016ltr.pdf
12/22/2020	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210455s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210455Orig1s012ltr.pdf
03/02/2020	SUPPL-9	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210455s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210455Orig1s009ltr.pdf
02/25/2019	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210455Orig1s005ltr.pdf
05/30/2019	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210455Orig1s004ltr.pdf
01/25/2019	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210455Orig1s001ltr.pdf

Labels for NDA 210455

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2023	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210455s023lbl.pdf
03/31/2023	SUPPL-23	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210455s023lbl.pdf
10/20/2022	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210455s022lbl.pdf
10/20/2022	SUPPL-22	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210455s022lbl.pdf
04/14/2022	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210455s020lbl.pdf
04/14/2022	SUPPL-20	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210455s020lbl.pdf
07/29/2021	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210455s016lbl.pdf
07/29/2021	SUPPL-16	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210455s016lbl.pdf
06/28/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210455s017lbl.pdf
12/22/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210455s012lbl.pdf
12/22/2020	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210455s012lbl.pdf
03/02/2020	SUPPL-9	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210455s009lbl.pdf
05/30/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s004lbl.pdf
05/30/2019	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s004lbl.pdf
02/25/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s005lbl.pdf
02/25/2019	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s005lbl.pdf
01/25/2019	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s001lbl.pdf
01/25/2019	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s001lbl.pdf
07/17/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210455s000lbl.pdf

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