MedPath
FDA Approval

Hydroxyzine Hydrochloride

March 9, 2015

HUMAN PRESCRIPTION DRUG LABEL

Hydroxyzine(10 mg in 5 mL)

Manufacturing Establishments (2)

Pharmaceutical Associates, Inc.

Pharmaceutical Associates, Inc.

097630693

Morton Grove

Pharmaceutical Associates, Inc.

801897505

Products (1)

Hydroxyzine Hydrochloride

0121-4822

ANDA087294

ANDA (C73584)

ORAL

March 9, 2015

SucroseInactive
Code: C151H8M554Class: IACT
alcoholInactive
Code: 3K9958V90MClass: IACT
Code: 76755771U3Class: ACTIBQuantity: 10 mg in 5 mL
MethylparabenInactive
Code: A2I8C7HI9TClass: IACT
Peppermint oilInactive
Code: AV092KU4JHClass: IACT
PropylparabenInactive
Code: Z8IX2SC1OHClass: IACT
Propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium CitrateInactive
Code: 1Q73Q2JULRClass: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QPClass: IACT
Spearmint oilInactive
Code: C3M81465G5Class: IACT
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