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DEXMEDETOMIDINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AM REGENT · Approved 2017-05-12

Drug application

FDA Application #

ANDA203773

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

Discontinued

Sponsor

AM REGENT

First approval

2017-05-12

Source

Authoritative

Drugs@FDA application overview

Machine

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