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AMIODARONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZHEJIANG POLY PHARM · Approved 2024-09-11

Drug application

FDA Application #
ANDA218253
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
ZHEJIANG POLY PHARM
Manufacturer
Slate Run Pharmaceuticals
First approval
2024-09-11

Source

Authoritative
Drugs@FDA application overview
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