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SAPROPTERIN DIHYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MICRO LABS · Approved 2026-01-08

Drug application

FDA Application #

ANDA219511

Application type

Abbreviated New Drug Application (Generic)

Brand name

SAPROPTERIN DIHYDROCHLORIDE

Generic name

SAPROPTERIN DIHYDROCHLORIDE

Active ingredients

SAPROPTERIN DIHYDROCHLORIDE

Dosage form

POWDER

Route

ORAL

Marketing status

Prescription

Sponsor

MICRO LABS

Manufacturer

Micro Labs Limited

First approval

2026-01-08

Source

Authoritative

Drugs@FDA application overview

Machine

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