Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203803
Company: MYLAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/29/2016 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2019 SUPPL-3 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

PROPAFENONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 225MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205268 GLENMARK PHARMS LTD
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203803 MYLAN
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078540 PAR PHARM
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210339 SINOTHERAPEUTICS INC
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212928 TWI PHARMS
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212744 UPSHER SMITH LABS
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202688 WATSON LABS INC
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205956 WILSHIRE PHARMS INC
RYTHMOL SR PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021416 GLAXOSMITHKLINE LLC

CAPSULE, EXTENDED RELEASE;ORAL; 325MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205268 GLENMARK PHARMS LTD
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203803 MYLAN
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078540 PAR PHARM
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210339 SINOTHERAPEUTICS INC
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212928 TWI PHARMS
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212744 UPSHER SMITH LABS
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202688 WATSON LABS INC
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205956 WILSHIRE PHARMS INC
RYTHMOL SR PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021416 GLAXOSMITHKLINE LLC

CAPSULE, EXTENDED RELEASE;ORAL; 425MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205268 GLENMARK PHARMS LTD
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203803 MYLAN
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078540 PAR PHARM
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210339 SINOTHERAPEUTICS INC
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212928 TWI PHARMS
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212744 UPSHER SMITH LABS
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202688 WATSON LABS INC
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205956 WILSHIRE PHARMS INC
RYTHMOL SR PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021416 GLAXOSMITHKLINE LLC

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