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ZANTAC 150

NDA

RANITIDINE HYDROCHLORIDE | N018703 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE

2 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 Chain4 active DMFs30 inactive

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

DR REDDYS LABORATORIES LTDRANITIDINE HYDROCHLORIDE (FORM I)

DMF 121661996

DR REDDYS LABORATORIES LTDRANITIDINE HYDROCHLORIDE [FORM-2]

DMF 201272007

ORCHEV PHARMA PVT LTDRANITIDINE HYDROCHLORIDE USP

DMF 258512012

SMS PHARMACEUTICALS LTDRANITIDINE HYDROCHLORIDE USP (PROCESS -2)

DMF 315752017

SHANGHAI NO 6 PHARMACEUTICAL FACTORYInactiveRANITIDINE HYDROCHLORIDE

DMF 75281988

QUIMICA SINTETICA SAInactiveRANITIDINE HYDROCHLORIDE

DMF 84941990

PHARMAGLOBE LABORATORIES LTDInactiveRANITIDINE HYDROCHLORIDE

DMF 89531991

FIRST SOUTHWEST PHARMACEUTICAL FACTORYInactiveRANITIDINE

DMF 90801991

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveRANITIDINE HYDROCHLORIDE (CRYSTALLINE FORM 1)

DMF 102731993

RANBAXY LABORATORIES LTDInactiveRANITIDINE HYDROCHLORIDE

DMF 105161993

CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTDInactiveRANITIDINE HYDROCHLORIDE

DMF 106821993

NOVOPHARM LTDInactiveRANITIDINE HYDROCHLORIDE USP

DMF 108851994

BOEHRINGER INGELHEIM CHEMICALS INCInactiveRANITIDINE HYDROCHLORIDE USP

DMF 114801995

MAPRIMED SAInactiveRANITIDINE HYDROCHLORIDE

DMF 115431995

DR REDDYS LABORATORIES LTDInactiveRANITIDINE

DMF 115461995

HOECHST MARION ROUSSEL INCInactiveRANITIDINE HYDROCHLORIDE USP, FORM 1

DMF 118241996

GENPHARM INCInactiveRANITIDINE HYDROCHLORIDE USP FORM 1

DMF 118391996

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveRANITIDINE HYDROCHLORIDE USP

DMF 122071996

NEULAND LABORATORIES LTDInactiveRANITIDINE

DMF 125031997

NEULAND LABORATORIES LTDInactiveRANITIDINE HYDROCHLORIDE (FORM I)

DMF 125321997

SOLARA ACTIVE PHARMA SCIENCES LTDInactiveRANITIDINE

DMF 125431997

WOCKHARDT LTDInactiveRANITIDINE HYDROCHLORIDE

DMF 125521997

SHASUN CHEMICALS AND DRUGS LTDInactiveRANITIDINE HYDROCHLORIDE

DMF 126651997

FAKO ILACLARI ASInactiveRANITIDINE HYDROCHLORIDE FORM I BULK

DMF 144151999

SOLARA ACTIVE PHARMA SCIENCES LTDInactiveRANITIDINE HYDROCHLORIDE

DMF 144681999

FAKO ILACLARI ASInactiveRANITIDINE HYDROCHLORIDE FORM I BULK

DMF 151252000

NEULAND LABORATORIES LTDInactiveRANITIDINE HYDROCHLORIDE USP

DMF 151412000

FARCHEMIA SRLInactiveRANITIDINE HYDROCHLORIDE

DMF 156762001

FAKO ILACLARI ASInactiveRANITIDINE HYDROCHLORIDE FORM II

DMF 159942002

SMS PHARMACEUTICALS LTDInactiveRANITIDINE HYDROCHLORIDE

DMF 175422004

SARACA LABORATORIES LTDInactiveRANITIDINE HYDROCHLORIDE (FORM-II)

DMF 176982004

SMS PHARMACEUTICALS LTDInactiveRANITIDINE HYDROCHLORIDE USP

DMF 181292005

WOCKHARDT LTDInactiveRANITIDINE HYDROCHLORIDE USP (FORM II)

DMF 195002006

SMS PHARMACEUTICALS LTDInactiveRANITIDINE HYDROCHLORIDE USP (UNIT-VII)

DMF 256082011

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Nov 12, 2009	SUPPL -68	View Letter (PDF)
Feb 19, 2009	SUPPL -67	View Letter (PDF)
Jul 21, 2006	SUPPL -66	View Letter (PDF)
May 2, 2005	SUPPL -65	View Letter (PDF)
Jul 1, 2004	SUPPL -56	View Letter (PDF)
Jan 7, 2002	SUPPL -61	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

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

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 9, 1983

No patent or exclusivity listings for this strength.

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

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 9, 1985