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SODIUM OXYBATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2025-09-10

Drug application

FDA Application #

ANDA203631

Application type

Abbreviated New Drug Application (Generic)

Brand name

SODIUM OXYBATE

Generic name

SODIUM OXYBATE

Active ingredients

SODIUM OXYBATE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

AMNEAL

Manufacturer

Amneal Pharmaceuticals LLC

First approval

2025-09-10

Source

Authoritative

Drugs@FDA application overview

Machine

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