Product Details for NDA 018703
ZANTAC 150 (RANITIDINE HYDROCHLORIDE)
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: RANITIDINE HYDROCHLORIDE
Proprietary Name: ZANTAC 150
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018703
Product Number: 001
Approval Date: Jun 9, 1983
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
ZANTAC 300 (RANITIDINE HYDROCHLORIDE)
Proprietary Name: ZANTAC 150
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018703
Product Number: 001
Approval Date: Jun 9, 1983
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: RANITIDINE HYDROCHLORIDE
Proprietary Name: ZANTAC 300
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018703
Product Number: 002
Approval Date: Dec 9, 1985
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ZANTAC 300
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018703
Product Number: 002
Approval Date: Dec 9, 1985
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information