Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078540
Company: PAR PHARM
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
10/18/2010 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078540s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078540Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

07/11/2011 SUPPL-2 Labeling-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 PHARMS INC
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 202688 WATSON LABS 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 PHARMS INC
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 202688 WATSON LABS 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 PHARMS INC
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 202688 WATSON LABS INC
RYTHMOL SR PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021416 GLAXOSMITHKLINE LLC

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