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ZANTAC Drug Profile

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Zantac is a drug marketed by Glaxo Grp Ltd, Igi Labs Inc, Glaxosmithkline, and Boehringer Ingelheim. and is included in nine NDAs. It is available from two suppliers.

The generic ingredient in ZANTAC is ranitidine hydrochloride. There are forty-two drug master file entries for this compound. One hundred and thirty-eight suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for Tradename: ZANTAC

Patents:0
Applicants:4
NDAs:9
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: ZANTAC

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp Ltd
ZANTAC
ranitidine hydrochloride
SYRUP;ORAL019675-001Dec 30, 1988RXYes► subscribe► subscribe
Boehringer Ingelheim
ZANTAC 150
ranitidine hydrochloride
TABLET;ORAL021698-001Aug 31, 2004OTCYes► subscribe► subscribe
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
GRANULE, EFFERVESCENT;ORAL020251-002Mar 31, 1994DISCNNo► subscribe► subscribe
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Expired Patents for Tradename: ZANTAC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ZANTAC
ranitidine hydrochloride
SYRUP;ORAL019675-001Dec 30, 19884,128,658► subscribe
Igi Labs Inc
ZANTAC
ranitidine hydrochloride
INJECTABLE;INJECTION019090-001Oct 19, 19844,128,658► subscribe
Igi Labs Inc
ZANTAC
ranitidine hydrochloride
INJECTABLE;INJECTION019090-001Oct 19, 19844,585,790*PED► subscribe
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Paragraph IV activity for: ZANTAC

Drugname Dosage Strength RLD Submissiondate
ranitidine hydrochlorideTablets150 mgZantac 15010/30/2007
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