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SACUBITRIL AND VALSARTAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVUGEN PHARMA SDN · Approved 2025-07-16

Drug application

FDA Application #

ANDA213611

Application type

Abbreviated New Drug Application (Generic)

Brand name

SACUBITRIL AND VALSARTAN

Generic name

SACUBITRIL AND VALSARTAN

Active ingredients

SACUBITRIL; VALSARTAN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

NOVUGEN PHARMA SDN

Manufacturer

Novugen Pharma (USA) LLC

First approval

2025-07-16

Source

Authoritative

Drugs@FDA application overview

Machine

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