Application 014694

Type
NDA
Sponsor
ASPEN GLOBAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002HEXADROLDEXAMETHASONE SODIUM PHOSPHATEINJECTABLE;INJECTIONEQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003HEXADROLDEXAMETHASONE SODIUM PHOSPHATEINJECTABLE;INJECTIONEQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004HEXADROLDEXAMETHASONE SODIUM PHOSPHATEINJECTABLE;INJECTIONEQ 20MG PHOSPHATE/MLNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78714SUPPL 2024-06-07
78681SUPPL 2024-06-06
53935ORIG2018-05-01
52435APPL2018-02-06
33125SUPPL2014-07-17
384SUPPL2014-07-17