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FDA ANDA · ANDA076550

PROPAFENONE HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA076550
TYPE
ANDA
ORIGINAL APPROVAL
2004-04-23
LATEST ACTION
2019-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PROPAFENONE HYDROCHLORIDEPrescription
PROPAFENONE HYDROCHLORIDE 300MG · TABLET · ORAL
PROPAFENONE HYDROCHLORIDEPrescription
PROPAFENONE HYDROCHLORIDE 150MG · TABLET · ORAL
PROPAFENONE HYDROCHLORIDEPrescription
PROPAFENONE HYDROCHLORIDE 225MG · TABLET · ORAL

Approval history

2019-10-30Labeling · Supplement 11 · standardAP
2004-04-23OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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