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Generated: May 27, 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 Generics, 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, Igi Labs Inc, Contract Pharmacal, Glaxosmithkline, and Perrigo, and is included in seventy NDAs. There is one patent protecting this compound and one Paragraph IV challenge. 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.

Summary for Generic Name: ranitidine hydrochloride

Drug Master File Entries: see list43
Suppliers / Packagers: see list142
Bulk Api Vendors: see list83
Clinical Trials: see list1,014
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ranitidine hydrochloride at DailyMed

Pharmacology for Ingredient: ranitidine hydrochloride

Tentative approvals for RANITIDINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► SubscribeEQ 150MG BASETABLET;ORAL
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
ranitidine hydrochloride
TABLET;ORAL074023-001Aug 22, 1997DISCNNoNo► Subscribe► Subscribe
ranitidine hydrochloride
TABLET;ORAL074467-002Aug 29, 1997ABRXNoNo► Subscribe► Subscribe
Zydus Pharms Usa Inc
ranitidine hydrochloride
INJECTABLE;INJECTION091534-001Feb 22, 2013APRXNoNo► Subscribe► Subscribe
ranitidine hydrochloride
TABLET;ORAL076195-001Aug 30, 2002OTCNoNo► Subscribe► Subscribe
ranitidine hydrochloride
TABLET;ORAL074023-002Aug 22, 1997DISCNNoNo► Subscribe► Subscribe
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