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Generated: November 20, 2018

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Details for New Drug Application (NDA): 019090

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NDA 019090 describes ZANTAC, which is a drug marketed by Teligent, Glaxo Grp Ltd, Glaxosmithkline, and Sanofi Us, and is included in nine NDAs. It is available from one supplier. 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. One hundred and forty-five suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 019090
Tradename:ZANTAC
Applicant:Teligent
Ingredient:ranitidine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019090
Suppliers and Packaging for NDA: 019090
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZANTAC ranitidine hydrochloride INJECTABLE;INJECTION 019090 NDA Teligent Pharma, Inc. 52565-096 52565-096-01 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (52565-096-01) > 40 mL in 1 VIAL, PHARMACY BULK PACKAGE
ZANTAC ranitidine hydrochloride INJECTABLE;INJECTION 019090 NDA Teligent Pharma, Inc. 52565-101 52565-101-01 10 VIAL in 1 CARTON (52565-101-01) > 2 mL in 1 VIAL

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
Teligent ZANTAC ranitidine hydrochloride INJECTABLE;INJECTION 019090-001 Oct 19, 1984 ➤ Sign Up ➤ Sign Up
Teligent ZANTAC ranitidine hydrochloride INJECTABLE;INJECTION 019090-001 Oct 19, 1984 ➤ Sign Up ➤ Sign Up
Teligent ZANTAC ranitidine hydrochloride INJECTABLE;INJECTION 019090-001 Oct 19, 1984 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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