Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207110
Company: WATSON LABS INC

• REMS

Products on ANDA 207110

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BOSENTAN	BOSENTAN	62.5MG	TABLET;ORAL	Prescription	AB	No	No
BOSENTAN	BOSENTAN	125MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207110

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-5	REMS - MODIFIED - D-N-A		Label is not available on this site.
11/04/2019	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207110

BOSENTAN

TABLET;ORAL; 62.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BOSENTAN	BOSENTAN	62.5MG	TABLET;ORAL	Prescription	No	AB	209324	SUN PHARM
BOSENTAN	BOSENTAN	62.5MG	TABLET;ORAL	Prescription	No	AB	207110	WATSON LABS INC
BOSENTAN	BOSENTAN	62.5MG	TABLET;ORAL	Prescription	No	AB	207760	ZYDUS PHARMS
TRACLEER	BOSENTAN	62.5MG	TABLET;ORAL	Prescription	Yes	AB	021290	ACTELION

TABLET;ORAL; 125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BOSENTAN	BOSENTAN	125MG	TABLET;ORAL	Prescription	No	AB	209324	SUN PHARM
BOSENTAN	BOSENTAN	125MG	TABLET;ORAL	Prescription	No	AB	207110	WATSON LABS INC
BOSENTAN	BOSENTAN	125MG	TABLET;ORAL	Prescription	No	AB	207760	ZYDUS PHARMS
TRACLEER	BOSENTAN	125MG	TABLET;ORAL	Prescription	Yes	AB	021290	ACTELION