Hydroxyzine Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hi-Tech Pharmacal Co., Inc. (2014-08-11)
Oldest Current Product
1982-01-01
License(s)
ANDA
RxNORM
ORAL SOLUTION\HYDROXYZINE
FDAOB
ORAL\SYRUP\HYDROXYZINE HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\HYDROXYZINE HYDROCHLORIDE
ORAL\SYRUP\HYDROXYZINE HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\HYDROXYZINE
ORAL\SYRUP\HYDROXYZINE

product(s) by strength(s)

hydroxyzine hydrochloride 2 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006031310ANDAQualitest Pharmaceuticals2002-04-10HYDROXYZINE HYDROCHLORIDEORALSOLUTIONANDA0403917bcab9cd-2ed9-48c1-b2f5-953ec522e4fc
2107020052ANDAKvk-Tech, Inc.2008-09-26HYDROXYZINE HYDROCHLORIDEORALSOLUTIONANDA0400109b85615f-7877-4b04-b376-d15d8e5feff2
3503830796ANDAHi-Tech Pharmacal Co., Inc.1994-10-28HYDROXYZINE HYDROCHLORIDEORALSOLUTIONANDA040010c848b1ae-2216-48f0-8646-165ecf7ed39b
4548380502ANDASilarx Pharmaceuticals, Inc2013-08-21HYDROXYZINE HYDROCHLORIDEORALSOLUTIONANDA201674a4fb61ae-aad6-4bd6-83fc-8b227f175df9
5604320150ANDAMorton Grove Pharmaceuticals, Inc.1995-03-09HYDROXYZINE HYDROCHLORIDEORALSYRUPANDA087294117aeccc-1a78-46d8-ad8d-4035870ad910

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1548790006ANDASti Pharma1982-01-01HYDROXYZINE HYDROCHLORIDEORALSOLUTIONANDA086880fe0c3083-2a8f-4f5f-af9f-b1f668e77417

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001214822ANDAPharmaceutical Associates, Inc.2015-01-01HYDROXYZINE HYDROCHLORIDEORALSYRUP604320150ANDA08729485e3c789-a740-4a09-a810-9808c3d0f7d9
2545691640ANDAA-S Medication Solutions Llc1995-03-09HYDROXYZINE HYDROCHLORIDEORALSYRUP604320150ANDA0872945d7e8f9b-2517-4bfa-bcd6-7a0525265d5d
3548682032ANDAPhysicians Total Care, Inc.1994-08-01HYDROXYZINE HYDROCHLORIDEORALSOLUTION503830796ANDA040010d689b73d-1bf1-41c7-b7a3-593c6d6812dd
4548684336ANDAPhysicians Total Care, Inc.2000-09-13HYDROXYZINE HYDROCHLORIDEORALSYRUP604320150ANDA087294989107f5-e3df-4519-98bc-3b6ed290758f
5631870494ANDAProficient Rx Lp1995-03-09HYDROXYZINE HYDROCHLORIDEORALSYRUP604320150ANDA087294bcddc5ce-6cfb-4a09-8e6c-c956b65e3188
6687889466ANDAPreferred Pharmaceuticals, Inc.2015-08-21HYDROXYZINE HYDROCHLORIDEORALSOLUTION548380502ANDA20167484691197-2289-4f2b-b1fb-086b7d91a299
7687889522ANDAPreferred Pharmaceuticals, Inc.2014-02-06HYDROXYZINE HYDROCHLORIDEORALSOLUTION107020052ANDA040010e3baaa92-8668-441c-a2cc-ca4f85e67d4a
8687889776ANDAPreferred Pharmaceuticals, Inc.2015-01-13HYDROXYZINE HYDROCHLORIDEORALSOLUTION503830796ANDA04001084065605-11a6-465c-a86c-ce0d7829091c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040010HYDROXYZINE HYDROCHLORIDEHI TECH PHARMACAL CO INC1994-10-28ANDA040010_001
2ANDA040391HYDROXYZINE HYDROCHLORIDEVINTAGE PHARMACEUTICALS INC2002-04-10ANDA040391_001
3ANDA086880HYDROXYZINE HYDROCHLORIDETrueSTI PHARMA LLCANDA086880_001
4ANDA087294HYDROXYZINE HYDROCHLORIDEWOCKHARDT EU OPERATIONS (SWISS) AG1982-04-12ANDA087294_001
5ANDA087730HYDROXYZINE HYDROCHLORIDETrueKV PHARMACEUTICAL CO1982-07-01ANDA087730_001
6ANDA088785HYDROXYZINE HYDROCHLORIDETrueALPHARMA US PHARMACEUTICALS DIVISION1988-02-03ANDA088785_001
7ANDA201674HYDROXYZINE HYDROCHLORIDESILARX PHARMACEUTICALS INC2013-08-21ANDA201674_001
8NDA010485ATARAXTrueROERIG DIV PFIZER INCNDA010485_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040010_001RXHYDROXYZINE HYDROCHLORIDE (10MG/5ML)ORALSYRUPTrueAA1994-10-28HYDROXYZINE HYDROCHLORIDE
2ANDA040391_001RXHYDROXYZINE HYDROCHLORIDE (10MG/5ML)ORALSYRUPTrueAA2002-04-10HYDROXYZINE HYDROCHLORIDE
3ANDA086880_001discontinuedHYDROXYZINE HYDROCHLORIDE (10MG/5ML)ORALSYRUPFalseHYDROXYZINE HYDROCHLORIDE
4ANDA087294_001RXHYDROXYZINE HYDROCHLORIDE (10MG/5ML)ORALSYRUPTrueAA1982-04-12HYDROXYZINE HYDROCHLORIDE
5ANDA087730_001discontinuedHYDROXYZINE HYDROCHLORIDE (10MG/5ML)ORALSYRUPFalse1982-07-01HYDROXYZINE HYDROCHLORIDE
6ANDA088785_001discontinuedHYDROXYZINE HYDROCHLORIDE (10MG/5ML)ORALSYRUPFalse1988-02-03HYDROXYZINE HYDROCHLORIDE
7ANDA201674_001RXHYDROXYZINE HYDROCHLORIDE (10MG/5ML)ORALSYRUPFalseAA2013-08-21HYDROXYZINE HYDROCHLORIDE
8NDA010485_001discontinuedHYDROXYZINE HYDROCHLORIDE (10MG/5ML)ORALSYRUPFalseATARAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1117aeccc-1a78-46d8-ad8d-4035870ad910 (view SPL)HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP (SYRUP)10 mg/5 mLprescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2014-08-136604320150
25d7e8f9b-2517-4bfa-bcd6-7a0525265d5d (view SPL)HYDROXYZINE HYDROCHLORIDE SYRUP, USP10 mg/5 mLprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545691640
37bcab9cd-2ed9-48c1-b2f5-953ec522e4fc (view SPL)HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USPprescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-07-217006031310
484065605-11a6-465c-a86c-ce0d7829091c (view SPL)HydrOXYzine Hydrochloride Oral Solution, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-01-132687889776
584691197-2289-4f2b-b1fb-086b7d91a299 (view SPL)HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg/5mLprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-08-211687889466
685e3c789-a740-4a09-a810-9808c3d0f7d9 (view SPL)HydrOXYzine HYDROCHLORIDE SYRUP USPprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE, REPACK2015-03-091001214822
7989107f5-e3df-4519-98bc-3b6ed290758f (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-01-052548684336
89b85615f-7877-4b04-b376-d15d8e5feff2 (view SPL)HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USPprescriptionHuman PrescriptionKvk-Tech, Inc.MANUFACTURE2012-08-291107020052
9a4fb61ae-aad6-4bd6-83fc-8b227f175df9 (view SPL)HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg/5mLprescriptionHuman PrescriptionSilarx Pharmaceuticals, Incmanufacture2014-06-247548380502
10bcddc5ce-6cfb-4a09-8e6c-c956b65e3188 (view SPL)HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP (SYRUP) 10 mg/5 mLprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870494
11c848b1ae-2216-48f0-8646-165ecf7ed39b (view SPL)HydrOXYzine Hydrochloride Oral Solution, USPprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.MANUFACTURE2014-08-115503830796
12d689b73d-1bf1-41c7-b7a3-593c6d6812dd (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-05-141548682032
13e3baaa92-8668-441c-a2cc-ca4f85e67d4a (view SPL)HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-02-102687889522
14fe0c3083-2a8f-4f5f-af9f-b1f668e77417 (view SPL)HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP (SYRUP)prescriptionHuman PrescriptionSti Pharma2014-06-132548790006

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII