Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211198
Company: AUROBINDO PHARMA LTD

• REMS

Products on ANDA 211198

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 211198

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/18/2023	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
09/05/2025	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/05/2025	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/02/2025	SUPPL-4	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/12/2024	SUPPL-3	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/11/2024	SUPPL-2	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/29/2024	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 211198

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	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	211123	SUN PHARM
OPSUMIT	MACITENTAN	10MG	TABLET;ORAL	Prescription	Yes	AB	204410	ACTELION