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DEXMEDETOMIDINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CAPLIN · Approved 2016-06-14

Drug application

FDA Application #

ANDA091465

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

CAPLIN

First approval

2016-06-14

Source

Authoritative

Drugs@FDA application overview

Machine

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