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Generated: November 23, 2017

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Ranitidine hydrochloride - Generic Drug Details

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What are the generic drug sources for ranitidine hydrochloride and what is the scope of ranitidine hydrochloride patent protection?

Ranitidine hydrochloride
is the generic ingredient in seven branded drugs marketed by Ranbaxy, Wockhardt, Apotex Inc, Bio Pharm Inc, Glaxo Grp Ltd, Pharm Assoc, Dr Reddys Labs Inc, Amneal Pharms, Strides Pharma, Watson Labs, Sandoz, Sanofi Us, Aurobindo Pharma Ltd, Mylan, Actavis Mid Atlantic, Amneal Pharms Ny, Watson Labs Inc, Perrigo R And D, Sun Pharm Inds Ltd, Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Tolmar, Teva, West-ward Pharms Int, Boehringer Ingelheim, Bedford, Ivax Sub Teva Pharms, Mylan Labs Ltd, Taro, Hi Tech Pharma, Apotex, Par Pharm, Breckenridge Pharm, Silarx, Teligent, Vintage Pharms, Nostrum Labs Inc, Contract Pharmacal, Glaxosmithkline, and Perrigo, and is included in seventy NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-three drug master file entries for ranitidine hydrochloride. One hundred and forty-two suppliers are listed for this compound. There are two tentative approvals for this compound.

Pharmacology for ranitidine hydrochloride

Tentative approvals for RANITIDINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► SubscribeEQ 150MG BASETABLET;ORAL
u► SubscribeEQ 300MG BASETABLET;ORAL
u► SubscribeEQ 25MG BASE/MLINJECTABLE;INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
TABLET;ORAL074488-002Jul 31, 1997ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
TABLET;ORAL078192-001Aug 31, 2007OTCNoNo► Subscribe► Subscribe► Subscribe
Apotex
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
TABLET;ORAL074680-002Sep 12, 1997ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Inc
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
TABLET;ORAL076705-002Jul 27, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Glaxo Grp Ltd
ZANTAC 25
ranitidine hydrochloride
TABLET, EFFERVESCENT;ORAL020251-003Apr 1, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
CAPSULE;ORAL075742-002Nov 29, 2000ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
TABLET;ORAL074467-001Aug 29, 1997ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
TABLET;ORAL074680-001Sep 12, 1997ABRXNoNo► Subscribe► Subscribe► Subscribe
Sanofi Us
ZANTAC 150
ranitidine hydrochloride
TABLET;ORAL021698-002Mar 13, 2007OTCYesNo► Subscribe► Subscribe► Subscribe
Mylan
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
TABLET;ORAL074552-001Jul 30, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ranitidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ZANTAC
ranitidine hydrochloride
SYRUP;ORAL019675-001Dec 30, 1988► Subscribe► Subscribe
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
TABLET, EFFERVESCENT;ORAL020251-001Mar 31, 1994► Subscribe► Subscribe
Sanofi Us
ZANTAC 150
ranitidine hydrochloride
TABLET;ORAL021698-002Mar 13, 2007► Subscribe► Subscribe
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
GRANULE, EFFERVESCENT;ORAL020251-002Mar 31, 1994► Subscribe► Subscribe
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
TABLET;ORAL018703-001Jun 9, 1983► Subscribe► Subscribe
Teligent
ZANTAC IN PLASTIC CONTAINER
ranitidine hydrochloride
INJECTABLE;INJECTION019593-002Sep 27, 1991► Subscribe► Subscribe
Teligent
ZANTAC
ranitidine hydrochloride
INJECTABLE;INJECTION019090-001Oct 19, 1984► Subscribe► Subscribe
Glaxosmithkline
ZANTAC 150
ranitidine hydrochloride
CAPSULE;ORAL020095-001Mar 8, 1994► Subscribe► Subscribe
Glaxo Grp Ltd
ZANTAC 300
ranitidine hydrochloride
TABLET;ORAL018703-002Dec 9, 1985► Subscribe► Subscribe
Glaxo Grp Ltd
ZANTAC 300
ranitidine hydrochloride
TABLET;ORAL018703-002Dec 9, 1985► Subscribe► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Accenture
Express Scripts
Moodys
UBS
Covington
Merck
Johnson and Johnson
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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