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HYDROXYUREA

These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES.HYDROXYUREA capsules, for oral useInitial U.S. Approval: 1967

Approved
Approval ID

b9514ae5-79ae-4cc2-9d7f-c8f7806d1694

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 7, 2022

Manufacturers
FDA

Teva Pharmaceuticals USA, Inc.

DUNS: 001627975

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydroxyurea

PRODUCT DETAILS

NDC Product Code0555-0882
Application NumberANDA075143
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 7, 2022
Generic NameHydroxyurea

INGREDIENTS (18)

HYDROXYUREAActive
Quantity: 500 mg in 1 1
Code: X6Q56QN5QC
Classification: ACTIB
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

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HYDROXYUREA - FDA Drug Approval Details