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FDA ANDA · ANDA203803

PROPAFENONE HYDROCHLORIDE

Sponsor: MYLAN

APPLICATION
ANDA203803
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-29
LATEST ACTION
2019-10-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PROPAFENONE HYDROCHLORIDEDiscontinued
PROPAFENONE HYDROCHLORIDE 325MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPAFENONE HYDROCHLORIDEDiscontinued
PROPAFENONE HYDROCHLORIDE 425MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPAFENONE HYDROCHLORIDEDiscontinued
PROPAFENONE HYDROCHLORIDE 225MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2019-10-30Labeling · Supplement 3 · standardAP
2016-04-29UNKNOWN · OriginalAP
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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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