Application 219935

Type
NDA
Sponsor
SAGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINEFAMOTIDINESOLUTION;INTRAVENOUS20MG/5ML (4MG/ML)YesYes
002FAMOTIDINEFAMOTIDINESOLUTION;INTRAVENOUS40MG/10ML (4MG/ML)YesYes
003FAMOTIDINEFAMOTIDINESOLUTION;INTRAVENOUS200MG/50ML (4MG/ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82900ORIG 2025-07-21
82888ORIG 2025-07-17