MedPath
FDA Approval

Hydroxyzine Hydrochloride

September 11, 2013

HUMAN PRESCRIPTION DRUG LABEL

Hydroxyzine(50 mg in 1 1)

Manufacturing Establishments (1)

State of Florida DOH Central Pharmacy

State of Florida DOH Central Pharmacy

829348114

Products (1)

Hydroxyzine Hydrochloride

53808-0632

ANDA040812

ANDA (C73584)

ORAL

September 11, 2013

Code: 76755771U3Class: ACTIBQuantity: 50 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
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