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MACITENTAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS LIFESCIENCES · Approved 2021-04-06

Drug application

FDA Application #
ANDA211224
Application type
Abbreviated New Drug Application (Generic)
Brand name
MACITENTAN
Generic name
Macitentan
Active ingredients
MACITENTAN
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
ZYDUS LIFESCIENCES
First approval
2021-04-06

Source

Authoritative
Drugs@FDA application overview
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