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AMIODARONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN INSTITUTIONAL · Approved 2002-10-15

Drug application

FDA Application #
ANDA076217
Application type
Abbreviated New Drug Application (Generic)
Brand name
AMIODARONE HYDROCHLORIDE
Generic name
AMIODARONE HYDROCHLORIDE
Active ingredients
AMIODARONE HYDROCHLORIDE
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription
Sponsor
MYLAN INSTITUTIONAL
Manufacturer
Mylan Institutional LLC
First approval
2002-10-15

Source

Authoritative
Drugs@FDA application overview
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