FdaApplication

NDA 022569

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Identifiers

Properties

PropertyValue
applicant_nameBTCP PHARMA LLC
application_typeNDA
approval_date2011-06-30

Products (3)

ProductActive ingredientStrengthDosage form
LAZANDAFENTANYL CITRATEEQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED;NASAL
LAZANDAFENTANYL CITRATEEQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED;NASAL
LAZANDAFENTANYL CITRATEEQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED;NASAL

3 products