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SAPROPTERIN DIHYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANNORA PHARMA · Approved 2022-08-18

Drug application

FDA Application #

ANDA215420

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

ANNORA PHARMA

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2022-08-18

Source

Authoritative

Drugs@FDA application overview

Machine

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