Manufacturing Establishments4
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Patheon Manufacturing Services LLC
Takeda Pharmaceuticals America, Inc.
079415560
Powdersize, LLC
Takeda Pharmaceuticals America, Inc.
080120056
Catalent Pharma Solutions, LLC
Takeda Pharmaceuticals America, Inc.
119332987
Sterling Wisconsin, LLC
Takeda Pharmaceuticals America, Inc.
054452136
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Agrylin
Product Details
NDC Product Code
54092-063Application Number
NDA020333Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 21, 2021AnagrelideActive
Code: VNS4435G39Class: ACTIMQuantity: 0.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT