Viewing data from:

RYTHMOL

NDA

PROPAFENONE HYDROCHLORIDE | N019151 | GLAXOSMITHKLINE LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs4 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

PHARMAZELL GMBHPROPAFENONE HYDROCHLORIDE

DMF 106411993

PROCOS SPAPROPAFENONE HYDROCHLORIDE

DMF 114261995

ERREGIERRE SPAPROPAFENONE HYDROCHLORIDE USP-EP

DMF 130101998

SCI PHARMTECH INCPROPAFENONE HYDROCHLORIDE

DMF 235372010

ZYDUS LIFESCIENCES LTDPROPAFENONE HYDROCHLORIDE USP

DMF 250552011

EMCURE PHARMACEUTICALS LTDPROPAFENONE HYDROCHLORIDE USP

DMF 255882012

CHANGZHOU RUIMING PHARMACEUTICAL CO LTDPROPAFENONE HYDROCHLORIDE

DMF 379642023

ORGAMOL SAInactivePROPAFENONE HYDROCHLORIDE

DMF 83111989

SIEGFRIED CHEMIE AG LTDInactivePROPAFENONE HYDROCHLORIDE

DMF 126911997

CAMBREX PROFARMACO MILANO SRLInactivePROPAFENONE HYDROCHLORIDE

DMF 149852000

MYLAN LABORATORIES LTDInactivePROPAFENONE HYDROCHLORIDE USP

DMF 204182007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Nov 7, 2018	SUPPL -15	View Letter (PDF)
Mar 22, 2013	SUPPL -12	View Letter (PDF)
Jun 16, 2004	SUPPL -9	View Letter (PDF)
Dec 5, 2002	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 27, 1989

No patent or exclusivity listings for this strength.

#002 — 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 27, 1989

#003 — 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 20, 1992