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MACITENTAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: RHODES PHARMS · Approved 2023-01-11

Drug application

FDA Application #

ANDA214112

Application type

Abbreviated New Drug Application (Generic)

Brand name

MACITENTAN

Generic name

Macitentan

Active ingredients

MACITENTAN

Dosage form

TABLET

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

RHODES PHARMS

First approval

2023-01-11

Source

Authoritative

Drugs@FDA application overview

Machine

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