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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218502
Company: ALKEM LABS LTD

Products on ANDA 218502

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIVAROXABAN	RIVAROXABAN	1MG/ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218502

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218502

RIVAROXABAN

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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