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Last Updated: March 29, 2024

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-three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 020251
Tradename:ZANTAC 25
Applicant:Glaxo Grp Ltd
Ingredient:ranitidine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Expired US 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;ORAL 020251-002 Mar 31, 1994 ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp Ltd ZANTAC 150 ranitidine hydrochloride TABLET, EFFERVESCENT;ORAL 020251-001 Mar 31, 1994 ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp Ltd ZANTAC 150 ranitidine hydrochloride GRANULE, EFFERVESCENT;ORAL 020251-002 Mar 31, 1994 ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp Ltd ZANTAC 150 ranitidine hydrochloride TABLET, EFFERVESCENT;ORAL 020251-001 Mar 31, 1994 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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