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Details for New Drug Application (NDA): 019675

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NDA 019675 describes ZANTAC, which 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 three suppliers. Additional details are available on the ZANTAC profile page.

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

Summary for NDA: 019675

Glaxo Grp Ltd
ranitidine hydrochloride
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrengthEQ 15MG BASE/ML
Approval Date:Dec 30, 1988TE:AARLD:Yes

Expired Orange Book Patents for NDA: 019675

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ranitidine hydrochloride
SYRUP;ORAL019675-001Dec 30, 19884,128,658► subscribe
Glaxo Grp Ltd
ranitidine hydrochloride
SYRUP;ORAL019675-001Dec 30, 19885,068,249*PED► subscribe
Glaxo Grp Ltd
ranitidine hydrochloride
SYRUP;ORAL019675-001Dec 30, 19884,521,431*PED► subscribe
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