Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211161
Company: MYLAN

Products on ANDA 211161

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211161

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211161Orig1s000TA_ltr.pdf

Therapeutic Equivalents for ANDA 211161

MACITENTAN

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MACITENTAN	MACITENTAN	10MG	TABLET;ORAL	Prescription	No	AB	211128	ALEMBIC
MACITENTAN	MACITENTAN	10MG	TABLET;ORAL	Prescription	No	AB	211000	AMNEAL
MACITENTAN	MACITENTAN	10MG	TABLET;ORAL	Prescription	No	AB	211195	APOTEX
MACITENTAN	MACITENTAN	10MG	TABLET;ORAL	Prescription	No	AB	211198	AUROBINDO PHARMA LTD
MACITENTAN	MACITENTAN	10MG	TABLET;ORAL	Prescription	No	AB	211120	LAURUS
MACITENTAN	MACITENTAN	10MG	TABLET;ORAL	Prescription	No	AB	211136	MSN
MACITENTAN	MACITENTAN	10MG	TABLET;ORAL	Prescription	No	AB	211161	MYLAN
MACITENTAN	MACITENTAN	10MG	TABLET;ORAL	Prescription	No	AB	211026	SEASONS BIOTECH
MACITENTAN	MACITENTAN	10MG	TABLET;ORAL	Prescription	No	AB	211123	SUN PHARM
MACITENTAN	MACITENTAN	10MG	TABLET;ORAL	Prescription	No	AB	211187	TEVA PHARMS USA INC
MACITENTAN	MACITENTAN	10MG	TABLET;ORAL	Prescription	No	AB	211107	TORRENT
MACITENTAN	MACITENTAN	10MG	TABLET;ORAL	Prescription	No	AB	211224	ZYDUS LIFESCIENCES
OPSUMIT	MACITENTAN	10MG	TABLET;ORAL	Prescription	Yes	AB	204410	ACTELION