MedPath
FDA Approval

Hydroxyzine Hydrochloride

August 17, 2023

HUMAN PRESCRIPTION DRUG LABEL

Hydroxyzine(25 mg in 1 1)

Registrants (1)

PD-Rx Pharmaceuticals, Inc.

156893695

Manufacturing Establishments (1)

PD-Rx Pharmaceuticals, Inc.

PD-Rx Pharmaceuticals, Inc.

PD-Rx Pharmaceuticals, Inc.

156893695

Products (1)

Hydroxyzine Hydrochloride

72789-216

ANDA088618

ANDA (C73584)

ORAL

August 17, 2023

HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816NClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: 76755771U3Class: ACTIBQuantity: 25 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
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