ANDA filer definition
ANDA filer means a party that owns or controls an ANDA filed
ANDA filer means a party that owns or controls an ANDA filed with the Food and Drug Administration or has the exclusive rights under that ANDA to distribute the ANDA product.
ANDA filer means the party to a Branded/Generic Supply Agreement or a Branded/Generic Agreement who controls an ANDA for the Subject Drug Product or has the exclusive right to distribute the Generic Product.
More Definitions of ANDA filer
ANDA filer means a party that owns or controls an ANDA
ANDA filer means a person who has filed or submitted an ANDA with the FDA.
ANDA filer means the party to a Branded/Generic Supply Agreement or a Branded/Generic Agreement who Controls the generic version of the Subject Drug Product.
ANDA filer means a party that owns or controls an ANDA filed with the Food and
ANDA filer means a party to a Brand/Generic Settlement who controls an ANDA for the Subject Drug Product or has the exclusive right under such ANDA to distribute the Subject Drug Product.
ANDA filer means a party who has filed an ANDA with the FDA.