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ZANTAC 150

NDA

RANITIDINE HYDROCHLORIDE | N021698 | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

53 trials from ClinicalTrials.gov — 1 recruiting, 38 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
: Vascular Function in Health and Disease NCT02966665	Phase 1	Recruiting	Russell Richardson	420	2008-09 → 2026-08
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued in Subjects in the US Only NCT00633412	Phase 3	Completed	AstraZeneca	400	2001-02 → 2003-03
Mechanisms of N-acetylcysteine Mediated Vascular Adverse Effects NCT01209455	N/A	Completed	University of Edinburgh	24	2011-01-03 → 2011-07-15
Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)NCT00247715	N/A	Completed	Radboud University Medical Center	664	2003-10 → 2007-01
Tiotropium in Combination With Concomitant Cimetidine or Ranitidine in Healthy Male and Female Subjects NCT02172417	Phase 1	Completed	Boehringer Ingelheim	18	2000-07
BMS 247550 to Treat Kidney Cancer NCT00030992	Phase 2	Completed	National Cancer Institute (NCI)	102	2002-02 → 2012-06
Prophylaxis for Aspiration of Gastric Contents.NCT02703896	Phase 4	Completed	King Saud University	1,920	2012-01 → 2015-12
Peanut Allergy Oral Immunotherapy Desensitization NCT01601522	Phase 2	Completed	Hamilton Health Sciences Corporation	43	2012-02 → 2021-09
Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects NCT00930670	Phase 4	Completed	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec	320	2009-06 → 2011-12
Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer NCT00401752	Phase 3	Completed	AstraZeneca	397	2006-03 → 2008-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain4 active DMFs31 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

SOLARA ACTIVE PHARMA SCIENCES LTDInactiveRANITIDINE HYDROCHLORIDE, USP (FORM II)

DMF 155292001

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

10 letters from Drugs@FDA

Date	Submission	Document
Sep 19, 2019	SUPPL -31	View Letter (PDF)
Apr 8, 2019	SUPPL -29	View Letter (PDF)
Aug 26, 2016	SUPPL -24	View Letter (PDF)
Aug 23, 2016	SUPPL -23	View Letter (PDF)
Mar 22, 2016	SUPPL -22	View Letter (PDF)
Dec 14, 2015	SUPPL -19	View Letter (PDF)
Nov 23, 2015	SUPPL -20	View Letter (PDF)
Mar 13, 2015	SUPPL -18	View Letter (PDF)
Mar 15, 2007	SUPPL -3	View Letter (PDF)
Sep 3, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 150MG BASE

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 31, 2004

No patent or exclusivity listings for this strength.

#002 — EQ 150MG BASE

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 13, 2007