APPLICATION
ANDA205268
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-08
LATEST ACTION
2019-10-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PROPAFENONE HYDROCHLORIDEPrescription
PROPAFENONE HYDROCHLORIDE 425MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPAFENONE HYDROCHLORIDEPrescription
PROPAFENONE HYDROCHLORIDE 225MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPAFENONE HYDROCHLORIDEPrescription
PROPAFENONE HYDROCHLORIDE 325MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2019-10-31Labeling · Supplement 1 · standardAP
2017-09-08UNKNOWN · Original · 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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