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Details for New Drug Application (NDA): 018703

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NDA 018703 describes ZANTAC 300, which is a drug marketed by Glaxo Grp Ltd and Glaxosmithkline and is included in two NDAs. It is available from one supplier. Additional details are available on the ZANTAC 300 profile page.

The generic ingredient in ZANTAC 300 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 NDA: 018703

Tradename:
ZANTAC 150
Applicant:
Glaxo Grp Ltd
Ingredient:
ranitidine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018703

Suppliers and Packaging for NDA: 018703

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZANTAC 150
ranitidine hydrochloride
TABLET;ORAL 018703 NDA GlaxoSmithKline LLC 0173-0344 0173-0344-42 60 TABLET, FILM COATED in 1 BOTTLE (0173-0344-42)
ZANTAC 300
ranitidine hydrochloride
TABLET;ORAL 018703 NDA GlaxoSmithKline LLC 0173-0344 0173-0344-42 60 TABLET, FILM COATED in 1 BOTTLE (0173-0344-42)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Jun 9, 1983TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Dec 9, 1985TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018703

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
TABLET;ORAL018703-001Jun 9, 19834,128,658► subscribe
Glaxo Grp Ltd
ZANTAC 300
ranitidine hydrochloride
TABLET;ORAL018703-002Dec 9, 19854,521,431*PED► subscribe
Glaxo Grp Ltd
ZANTAC 300
ranitidine hydrochloride
TABLET;ORAL018703-002Dec 9, 19854,128,658► subscribe
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