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SODIUM OXYBATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: OHM LABS INC · Approved 2017-01-19

Drug application

FDA Application #

ANDA203351

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

None (Tentative Approval)

Sponsor

OHM LABS INC

First approval

2017-01-19

Source

Authoritative

Drugs@FDA application overview

Machine

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