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PROPAFENONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2016-05-11

Drug application

FDA Application #
ANDA202445
Application type
Abbreviated New Drug Application (Generic)
Brand name
PROPAFENONE HYDROCHLORIDE
Generic name
PROPAFENONE HYDROCHLORIDE
Active ingredients
PROPAFENONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
AUROBINDO PHARMA
Manufacturer
Aurobindo Pharma Limited
First approval
2016-05-11

Source

Authoritative
Drugs@FDA application overview
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