Drugs@FDA document

AMBRISENTAN REMS · ANDA 210784 ORIG-1

Drugs@FDA document · SUN PHARM · Nov 6, 2023

Key facts

Drug name AMBRISENTAN
Document type REMS
Application ANDA210784
Submission ORIG-1
Company SUN PHARM
Document date Nov 6, 2023
FDA document accessdata.fda.gov

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About Drugs@FDA documents

Drugs@FDA posts the letters, labels, reviews and other documents behind each drug application and supplement. Orca1 indexes every document's full text and flags complete response letters.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA application documents · Source date:

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