Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208534
Company: DR REDDYS

Products on ANDA 208534

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	AB	No	No
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	AB	No	No
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	AB	No	No
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208534

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208534

RIVAROXABAN

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	210301	ALEMBIC
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	217810	APOTEX
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	219332	ASCENT PHARMS INC
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	208544	AUROBINDO PHARMA LTD
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	218107	BIOCON PHARMA
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	208534	DR REDDYS
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	208555	LUPIN LTD
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	213114	MACLEODS PHARMS LTD
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	208546	MSN
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	218445	REGCON HOLDINGS
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	218117	SCIEGEN PHARMS
RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	208557	TARO
XARELTO	RIVAROXABAN	2.5MG	TABLET;ORAL	Prescription	Yes	AB	022406	JANSSEN PHARMS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	216995	AIPING PHARM INC
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	210301	ALEMBIC
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	208579	APOTEX
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	219332	ASCENT PHARMS INC
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	208544	AUROBINDO PHARMA LTD
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	218107	BIOCON PHARMA
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	208220	BRECKENRIDGE
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	208534	DR REDDYS
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	208555	LUPIN LTD
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	213114	MACLEODS PHARMS LTD
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	218445	REGCON HOLDINGS
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	218117	SCIEGEN PHARMS
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	213348	SUNSHINE
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	No	AB	208557	TARO
XARELTO	RIVAROXABAN	10MG	TABLET;ORAL	Prescription	Yes	AB	022406	JANSSEN PHARMS

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	216995	AIPING PHARM INC
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	210301	ALEMBIC
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	208579	APOTEX
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	219332	ASCENT PHARMS INC
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	208544	AUROBINDO PHARMA LTD
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	218107	BIOCON PHARMA
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	208220	BRECKENRIDGE
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	208534	DR REDDYS
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	208555	LUPIN LTD
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	213114	MACLEODS PHARMS LTD
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	218445	REGCON HOLDINGS
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	218117	SCIEGEN PHARMS
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	213348	SUNSHINE
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	No	AB	208557	TARO
XARELTO	RIVAROXABAN	15MG	TABLET;ORAL	Prescription	Yes	AB	022406	JANSSEN PHARMS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	216995	AIPING PHARM INC
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	210301	ALEMBIC
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	208579	APOTEX
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	219332	ASCENT PHARMS INC
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	208544	AUROBINDO PHARMA LTD
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	218107	BIOCON PHARMA
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	208220	BRECKENRIDGE
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	208534	DR REDDYS
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	208555	LUPIN LTD
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	213114	MACLEODS PHARMS LTD
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	218445	REGCON HOLDINGS
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	218117	SCIEGEN PHARMS
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	213348	SUNSHINE
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	No	AB	208557	TARO
XARELTO	RIVAROXABAN	20MG	TABLET;ORAL	Prescription	Yes	AB	022406	JANSSEN PHARMS