APPLICATION
ANDA075938
TYPE
ANDA
ORIGINAL APPROVAL
2002-10-17
LATEST ACTION
2024-10-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PROPAFENONE HYDROCHLORIDEPrescription
PROPAFENONE HYDROCHLORIDE 225MG · TABLET · ORAL
PROPAFENONE HYDROCHLORIDEPrescription
PROPAFENONE HYDROCHLORIDE 300MG · TABLET · ORAL
PROPAFENONE HYDROCHLORIDEPrescription
PROPAFENONE HYDROCHLORIDE 150MG · TABLET · ORAL
Approval history
2024-10-17Labeling · Supplement 19 · standardAP
2024-10-17Labeling · Supplement 23 · standardAP
2016-05-29Labeling · Supplement 14 · standardAP
2015-08-27Labeling · Supplement 11 · standardAP
2006-05-04Labeling · Supplement 4AP
2002-10-17OriginalAP
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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