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DEXMEDETOMIDINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN INSTITUTIONAL · Approved 2014-08-18

Drug application

FDA Application #
ANDA202881
Application type
Abbreviated New Drug Application (Generic)
Brand name
DEXMEDETOMIDINE HYDROCHLORIDE
Generic name
DEXMEDETOMIDINE
Active ingredients
DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription
Sponsor
MYLAN INSTITUTIONAL
Manufacturer
Mylan Institutional LLC
First approval
2014-08-18

Source

Authoritative
Drugs@FDA application overview
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