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ZELVYSIA

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUCTA · Approved 2025-04-29

Drug application

FDA Application #

ANDA218645

Application type

Abbreviated New Drug Application (Generic)

Brand name

ZELVYSIA

Generic name

SAPROPTERIN DIHYDROCHLORIDE

Active ingredients

SAPROPTERIN DIHYDROCHLORIDE

Dosage form

POWDER

Route

ORAL

Marketing status

Prescription

Sponsor

AUCTA

Manufacturer

Aucta Pharmaceuticals, Inc.

First approval

2025-04-29

Source

Authoritative

Drugs@FDA application overview

Machine

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