Product Details for NDA 019510
PEPCID (FAMOTIDINE)
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: INJECTABLE; INJECTION
Strength: 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019510
Product Number: 001
Approval Date: Nov 4, 1986
Applicant Holder Full Name: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PEPCID PRESERVATIVE FREE (FAMOTIDINE)
Proprietary Name: PEPCID
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019510
Product Number: 001
Approval Date: Nov 4, 1986
Applicant Holder Full Name: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FAMOTIDINE
Proprietary Name: PEPCID PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019510
Product Number: 004
Approval Date: Nov 4, 1986
Applicant Holder Full Name: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PEPCID PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019510
Product Number: 004
Approval Date: Nov 4, 1986
Applicant Holder Full Name: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information