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Details for New Drug Application (NDA): 020251

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NDA 020251 describes ZANTAC 25, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. Additional details are available on the ZANTAC 25 profile page.

The generic ingredient in ZANTAC 25 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: 020251

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EFFERVESCENT;ORALStrengthEQ 150MG BASE
Approval Date:Mar 31, 1994TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:GRANULE, EFFERVESCENT;ORALStrengthEQ 150MG BASE/PACKET
Approval Date:Mar 31, 1994TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EFFERVESCENT;ORALStrengthEQ 25MG BASE
Approval Date:Apr 1, 2004TE:RLD:No

Expired Orange Book Patents for NDA: 020251

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
GRANULE, EFFERVESCENT;ORAL020251-002Mar 31, 19944,128,658► subscribe
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
TABLET, EFFERVESCENT;ORAL020251-001Mar 31, 19944,521,431*PED► subscribe
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
TABLET, EFFERVESCENT;ORAL020251-001Mar 31, 19944,128,658► subscribe
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