Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 017920

Expand all

TAGAMET (CIMETIDINE)
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CIMETIDINE
Proprietary Name: TAGAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017920
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information

TAGAMET (CIMETIDINE)
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CIMETIDINE
Proprietary Name: TAGAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017920
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information

TAGAMET (CIMETIDINE)
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CIMETIDINE
Proprietary Name: TAGAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017920
Product Number: 004
Approval Date: Dec 14, 1983
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information

TAGAMET (CIMETIDINE)
800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CIMETIDINE
Proprietary Name: TAGAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 800MG **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: N017920
Product Number: 005
Approval Date: Apr 30, 1986
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information