Application 219935

Type
NDA
Sponsor
SAGENT

Related Records

Application Products

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

Documents

DocumentSubmission typeDate
82900ORIG 2025-07-21
82888ORIG 2025-07-17