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SACUBITRIL AND VALSARTAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2026-09-02

Drug application

FDA Application #
ANDA213631
Application type
Abbreviated New Drug Application (Generic)
Brand name
SACUBITRIL AND VALSARTAN
Generic name
Sacubitril
Active ingredients
SACUBITRIL; VALSARTAN
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
AUROBINDO PHARMA LTD
First approval
2026-09-02

Source

Authoritative
Drugs@FDA application overview
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