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DANTROLENE SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2017-06-19

Drug application

FDA Application #

ANDA204762

Application type

Abbreviated New Drug Application (Generic)

Brand name

DANTROLENE SODIUM

Generic name

DANTROLENE

Active ingredients

DANTROLENE SODIUM

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

HIKMA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2017-06-19

Source

Authoritative

Drugs@FDA application overview

Machine

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