FDA.reportPublic FDA data

Application 088713

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HY-PAM ""25""HYDROXYZINE PAMOATECAPSULE;ORALEQ 25MG HYDROCHLORIDENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088713-001HY-PAM "25"HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORAL1985-03-04

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A088713-001HY-PAM "25"EQ 25MG HYDROCHLORIDECAPSULE / ORAL1985-03-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088713-001HY-PAM "25"EQ 25MG HYDROCHLORIDECAPSULE / ORAL1985-03-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A088713-001HY-PAM "25"EQ 25MG HYDROCHLORIDECAPSULE / ORAL1985-03-04a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.0c9101ee-0746-4833-83cf-d0d09e52c0a92026-08-05Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.561d8abe-97e8-5dc7-e063-6294a90a39232026-07-08Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.6432d1aa-1e73-469e-835b-43d518963f712026-07-07Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.2e59dc14-7e17-4663-bc1f-7ee8e104dbfa2026-06-24Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.55012f2c-fa10-2a31-e063-6294a90ae7182026-06-24Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
Hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.55033469-f5c6-5180-e063-6394a90af5eb2026-06-24Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
Hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.5505ef8f-0322-b705-e063-6394a90a5c5c2026-06-24Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoateHYDROXYZINE PAMOATECoupler LLC545f0e87-2688-5381-e063-6394a90a72d42026-06-16Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
Hydroxyzine PamoateHYDROXYZINE PAMOATEAmneal Pharmaceuticals of New York LLCbc82aaaf-30c7-4afe-a908-d138ea1268ef2026-06-11Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoateHYDROXYZINE PAMOATECardinal Health 107, LLC6ffb7c82-f780-4527-a7c3-e7d0f7b3b91e2026-05-18Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
Hydroxyzine pamoateHYDROXYZINE PAMOATECoupler LLC509e9a9c-23a3-ade4-e063-6294a90a74032026-04-29Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoateHYDROXYZINE PAMOATECoupler LLC5020c699-6fc5-b166-e063-6294a90a58812026-04-23Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
Hydroxyzine PamoateHYDROXYZINE PAMOATEDirect_Rx8a7084e0-530c-607b-e053-2a95a90a229c2026-03-05Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
Hydroxyzine PamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.a21df116-501f-4818-ad10-ccfa7b03d7ad2026-02-11Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoateHYDROXYZINE PAMOATEPreferred Pharmaceuticals Inc.b903f7e1-250d-46d8-a1ec-3f1dabc597f12026-01-23Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
Hydroxyzine PamoateHYDROXYZINE PAMOATEAvPAKbff08c15-89b1-00f7-e053-2995a90a2ad82026-01-08Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoateHYDROXYZINE PAMOATENorthwind Health Company, LLC127617c2-9775-3859-e063-6394a90a77cd2026-01-05Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
Hydroxyzine PamoateHYDROXYZINE PAMOATENorthwind Health Company, LLCfaf7932b-40ee-8822-e053-6394a90a5e402026-01-01Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoateHYDROXYZINE PAMOATENorthwind Health Company, LLCf99da162-f224-1c19-e053-6294a90acffb2026-01-01Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoateHYDROXYZINE PAMOATENorthwind Health Company, LLCdb8987d6-9814-50f6-e053-2a95a90a82a92026-01-01Warnings, Adverse reactionsName fallback
generic name: HYDROXYZINE PAMOATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.