Agrylin
These highlights do not include all the information needed to use AGRYLIN safely and effectively. See full prescribing information for AGRYLIN. AGRYLIN (anagrelide) capsules, for oral useInitial U.S. Approval: 1997
Approved
Approval ID
cb960074-99c1-4a73-941f-f0644a7ec219
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
anagrelide hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-063
Application NumberNDA020333
Product Classification
M
Marketing Category
C73594
G
Generic Name
anagrelide hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2021
FDA Product Classification
INGREDIENTS (7)
ANAGRELIDE HYDROCHLORIDE ANHYDROUSActive
Quantity: 0.5 mg in 1 1
Code: VNS4435G39
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT