← FDA Drug Approvals (Drugs@FDA)

AMBRISENTAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SIGMAPHARM LABS LLC · Approved 2019-04-10

Drug application

FDA Application #

ANDA208354

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMBRISENTAN

Generic name

AMBRISENTAN

Active ingredients

AMBRISENTAN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

SIGMAPHARM LABS LLC

Manufacturer

Sigmapharm Laboratories, LLC

First approval

2019-04-10

Source

Authoritative

Drugs@FDA application overview

Machine

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