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Last Updated: May 20, 2022

Details for New Drug Application (NDA): 019090


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NDA 019090 describes ZANTAC, which is a drug marketed by Pai Holdings Pharm, Glaxo Grp Ltd, Glaxosmithkline, and Chattem Sanofi, and is included in nine NDAs. Additional details are available on the ZANTAC profile page.

The generic ingredient in ZANTAC is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 019090
Tradename:ZANTAC
Applicant:Pai Holdings Pharm
Ingredient:ranitidine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 25MG BASE/ML
Approval Date:Oct 19, 1984TE:APRLD:Yes

Expired US Patents for NDA 019090

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pai Holdings Pharm ZANTAC ranitidine hydrochloride INJECTABLE;INJECTION 019090-001 Oct 19, 1984 See Plans and Pricing See Plans and Pricing
Pai Holdings Pharm ZANTAC ranitidine hydrochloride INJECTABLE;INJECTION 019090-001 Oct 19, 1984 See Plans and Pricing See Plans and Pricing
Pai Holdings Pharm ZANTAC ranitidine hydrochloride INJECTABLE;INJECTION 019090-001 Oct 19, 1984 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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