Application 215400

Type
NDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BREKIYA (AUTOINJECTOR)DIHYDROERGOTAMINE MESYLATESOLUTION;SUBCUTANEOUS1MG/MLYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85753ORIG 2026-04-27
82303ORIG 2025-05-23
82292ORIG 2025-05-14
82291ORIG 2025-05-14