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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215859
Company: JANSSEN PHARMS

Medication Guide

Products on NDA 215859

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XARELTO	RIVAROXABAN	1MG/ML	FOR SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215859

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2021	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215859Orig1s000correctedLBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215859Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215859Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2025	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022406s044,215859s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022406Orig1s044;215859Orig1s005ltr.pdf
02/08/2023	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215859s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022406Orig1s041;215859Orig1s002ltr.pdf

Labels for NDA 215859

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2025	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022406s044,215859s005lbl.pdf
06/17/2025	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022406s044,215859s005lbl.pdf
02/08/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215859s002lbl.pdf
12/20/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215859Orig1s000correctedLBL.pdf

Therapeutic Equivalents for NDA 215859

XARELTO

FOR SUSPENSION;ORAL; 1MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RIVAROXABAN	RIVAROXABAN	1MG/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	218502	ALKEM LABS LTD
RIVAROXABAN	RIVAROXABAN	1MG/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	218195	LUPIN LTD
XARELTO	RIVAROXABAN	1MG/ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	215859	JANSSEN PHARMS

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