Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213154
Company: NATCO PHARMA LTD

Products on ANDA 213154

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BOSENTAN	BOSENTAN	32MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213154

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213154Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2025	SUPPL-4	REMS - MODIFIED - D-N-A		Label is not available on this site.
02/21/2025	SUPPL-2	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 213154

BOSENTAN

TABLET, FOR SUSPENSION;ORAL; 32MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BOSENTAN	BOSENTAN	32MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	213154	NATCO PHARMA LTD
TRACLEER	BOSENTAN	32MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	209279	ACTELION