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GLYCEROL PHENYLBUTYRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2026-04-30

Drug application

FDA Application #
ANDA207694
Application type
Abbreviated New Drug Application (Generic)
Brand name
GLYCEROL PHENYLBUTYRATE
Generic name
Glycerol Phenylbutyrate
Active ingredients
GLYCEROL PHENYLBUTYRATE
Dosage form
LIQUID
Route
ORAL
Marketing status
Prescription
Sponsor
LUPIN
First approval
2026-04-30

Source

Authoritative
Drugs@FDA application overview
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