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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211107
Company: TORRENT

Products on ANDA 211107

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 211107

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/05/2024	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
04/02/2025	SUPPL-2	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/12/2024	SUPPL-1	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 211107

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

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