APPLICATION
ANDA078540
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-18
LATEST ACTION
2015-07-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PROPAFENONE HYDROCHLORIDEPrescription
PROPAFENONE HYDROCHLORIDE 325MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPAFENONE HYDROCHLORIDEPrescription
PROPAFENONE HYDROCHLORIDE 425MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPAFENONE HYDROCHLORIDEPrescription
PROPAFENONE HYDROCHLORIDE 225MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2015-07-10Labeling · Supplement 4 · standardAP
2011-07-11Labeling · Supplement 2AP
2010-10-18UNKNOWN · Supplement 3 · standardAP
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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