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DEXMEDETOMIDINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2015-09-18

Drug application

FDA Application #

ANDA201072

Application type

Abbreviated New Drug Application (Generic)

Brand name

DEXMEDETOMIDINE HYDROCHLORIDE

Generic name

DEXMEDETOMIDINE HYDROCHLORIDE

Active ingredients

DEXMEDETOMIDINE HYDROCHLORIDE

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

FRESENIUS KABI USA

Manufacturer

Fresenius Kabi USA, LLC

First approval

2015-09-18

Source

Authoritative

Drugs@FDA application overview

Machine

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