Product Details for NDA 019462
PEPCID (FAMOTIDINE)
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FAMOTIDINE
Proprietary Name: PEPCID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019462
Product Number: 001
Approval Date: Oct 15, 1986
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
PEPCID (FAMOTIDINE)
Proprietary Name: PEPCID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019462
Product Number: 001
Approval Date: Oct 15, 1986
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FAMOTIDINE
Proprietary Name: PEPCID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019462
Product Number: 002
Approval Date: Oct 15, 1986
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PEPCID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019462
Product Number: 002
Approval Date: Oct 15, 1986
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status: Discontinued
Patent and Exclusivity Information