Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 219935

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FAMOTIDINE (FAMOTIDINE)
20MG/5ML (4MG/ML)
Marketing Status: Discontinued

Active Ingredient: FAMOTIDINE
Proprietary Name: FAMOTIDINE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 20MG/5ML (4MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N219935
Product Number: 001
Approval Date: Jul 16, 2025
Applicant Holder Full Name: SAGENT PHARMACEUTICALS
Marketing Status:  Discontinued
Patent and Exclusivity Information

FAMOTIDINE (FAMOTIDINE)
40MG/10ML (4MG/ML)
Marketing Status: Discontinued

Active Ingredient: FAMOTIDINE
Proprietary Name: FAMOTIDINE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 40MG/10ML (4MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N219935
Product Number: 002
Approval Date: Jul 16, 2025
Applicant Holder Full Name: SAGENT PHARMACEUTICALS
Marketing Status:  Discontinued
Patent and Exclusivity Information

FAMOTIDINE (FAMOTIDINE)
200MG/50ML (4MG/ML)
Marketing Status: Discontinued

Active Ingredient: FAMOTIDINE
Proprietary Name: FAMOTIDINE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 200MG/50ML (4MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N219935
Product Number: 003
Approval Date: Jul 16, 2025
Applicant Holder Full Name: SAGENT PHARMACEUTICALS
Marketing Status:  Discontinued
Patent and Exclusivity Information