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PROPAFENONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS LIFESCIENCES · Approved 2021-04-21

Drug application

FDA Application #
ANDA214184
Application type
Abbreviated New Drug Application (Generic)
Brand name
PROPAFENONE HYDROCHLORIDE
Generic name
PROPAFENONE HYDROCHLORIDE
Active ingredients
PROPAFENONE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
ZYDUS LIFESCIENCES
Manufacturer
Zydus Lifesciences Limited
First approval
2021-04-21

Source

Authoritative
Drugs@FDA application overview
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