anagrelide
These highlights do not include all the information needed to use ANAGRELIDE CAPSULES safely and effectively. See full prescribing information for ANAGRELIDE CAPSULES ANAGRELIDE capsules, for oral use Initial U.S. Approval:1997
Approved
Approval ID
875cc32a-219c-4b6b-802a-98a47cbc9a78
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 21, 2022
Manufacturers
FDA
Torrent Pharmaceuticals Limited
DUNS: 916488547
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
anagrelide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13668-453
Application NumberANDA209151
Product Classification
M
Marketing Category
C73584
G
Generic Name
anagrelide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2022
FDA Product Classification
INGREDIENTS (12)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
ANAGRELIDE HYDROCHLORIDE ANHYDROUSActive
Quantity: 0.5 mg in 1 1
Code: VNS4435G39
Classification: ACTIM
anagrelide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13668-462
Application NumberANDA209151
Product Classification
M
Marketing Category
C73584
G
Generic Name
anagrelide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2022
FDA Product Classification
INGREDIENTS (12)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ANAGRELIDE HYDROCHLORIDE ANHYDROUSActive
Quantity: 1 mg in 1 1
Code: VNS4435G39
Classification: ACTIM