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Active ingredient

Ambrisentan

26 finished FDA listings contain Ambrisentan as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
AMBRISENTAN
Dosage forms
Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
13
Strengths listed
10 mg/1 · 5 mg/1
Brand names in FDA listings
Letairis

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 358274

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 022081GILEAD2007-06-152
ANDA 210058ZYDUS PHARMS2019-03-286
ANDA 208441MYLAN2019-03-282
ANDA 208252WATSON LABS INC2019-03-282
ANDA 210784SUN PHARM2019-03-282
ANDA 208354SIGMAPHARM LABS LLC2019-04-102
ANDA 210715CIPLA2019-04-262
ANDA 210701APOTEX2022-05-194
ANDA 216531AUROBINDO PHARMA2022-07-214

Official labeling on DailyMed

Showing the 12 most recent of 14 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.