← FDA DRUG APPROVALS

FDA ANDA · ANDA075998

PROPAFENONE HYDROCHLORIDE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA075998
TYPE
ANDA
ORIGINAL APPROVAL
2001-11-29
LATEST ACTION
2019-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2019-10-31Labeling · Supplement 20 · standardAP
2003-10-24Labeling · Supplement 5AP
2002-06-18Manufacturing (CMC) · Supplement 1AP
2001-11-29Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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