FDA Orange Book · active-ingredient family
Hydroxyzine pamoate
Hydroxyzine pamoate: 2 brands, 35 generics; first approved Mar 05, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 35 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
35
Listed patents
0
Presentations
41
Brand (NDA) products
Originator applications
- VISTARILRLDPFIZERNDA 011459-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Discontinued - EQ 50MG HYDROCHLORIDE CAPSULE ORAL Discontinued - EQ 100MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - VISTARILRLDPFIZERNDA 011795-
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE/5ML SUSPENSION ORAL Discontinued -
Generic (ANDA) products (35)
Abbreviated applications
- HYDROXYZINE PAMOATEHERITAGE PHARMAANDA 20150720132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Rx AB EQ 50MG HYDROCHLORIDE CAPSULE ORAL Rx AB - HYDROXYZINE PAMOATEIMPAX LABS INCANDA 04015619962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Rx AB EQ 50MG HYDROCHLORIDE CAPSULE ORAL Rx AB - HYDROXYZINE PAMOATEWATSON LABSANDA 0811651991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEBEXIMCO PHARMS USAANDA 0811271991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATESANDOZANDA 0811281991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATESANDOZANDA 0811291991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATESUPERPHARMANDA 0890311987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATESUPERPHARMANDA 0890321987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATESUPERPHARMANDA 0890331987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEPAR PHARMANDA 0891451986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEPAR PHARMANDA 0891461986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - TEVAANDA 0887131985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEBARRANDA 0884961984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Rx AB - HYDROXYZINE PAMOATEBARR LABSANDA 0884871984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG HYDROCHLORIDE CAPSULE ORAL Rx AB - HYDROXYZINE PAMOATEBARR LABSANDA 0884881984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG HYDROCHLORIDE CAPSULE ORAL Rx - - HYDROXYZINE PAMOATEDURAMED PHARMS BARRANDA 0885931984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEDURAMED PHARMS BARRANDA 0885941984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEDURAMED PHARMS BARRANDA 0885951984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEVANGARDANDA 0883921983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEVANGARDANDA 0883931983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEWATSON LABSANDA 0867281982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEWATSON LABSANDA 0877671982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEWATSON LABSANDA 0877901982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEWATSON LABSANDA 0868401982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEWATSON LABSANDA 0867051982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEPAR PHARMANDA 0876561982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEPAR PHARMANDA 0876571982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEPAR PHARMANDA 0876581982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEIVAX SUB TEVA PHARMSANDA 0877611982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEIVAX SUB TEVA PHARMSANDA 0877601982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATESANDOZANDA 087479-
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Rx AB - HYDROXYZINE PAMOATESANDOZANDA 086183-
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG HYDROCHLORIDE CAPSULE ORAL Rx AB - HYDROXYZINE PAMOATEWATSON LABSANDA 086698-
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEWATSON LABSANDA 086695-
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - HYDROXYZINE PAMOATEWATSON LABSANDA 086697-
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG HYDROCHLORIDE CAPSULE ORAL Discontinued -
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
45 yr 3 mo ago
Most recent approval
13 yr 7 mo ago
Approvals span 1982–2013 across 37 FDA applications.
Brand (NDA) 25%
Generic (ANDA) 3595%
Hydroxyzine pamoate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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