FDA.reportPublic FDA data

Application 087408

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEINJECTABLE;INJECTION25MG/MLNoYes
002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEINJECTABLE;INJECTION50MG/MLNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087408-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982
A087408-002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A087408-001HYDROXYZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONRS, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A087408-002HYDROXYZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONRS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087408-001HYDROXYZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONRS, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A087408-002HYDROXYZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONRS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087408-001HYDROXYZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONRS, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087408-002HYDROXYZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONRS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087408-001HYDROXYZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087408-002HYDROXYZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982a50c72e98297…

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEHenry Schein, Inc.7279ad5a-0a49-432d-8fa2-17e4c6ecbadc2025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087408
application number: ANDA087408
ndc (product): 0404-9877
HydroxyzineHYDROXYZINEHenry Schein, Inc.851e7439-bb0a-4a09-9279-e3c33bff89652025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087408
application number: ANDA087408
ndc (product): 0404-9878
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAmerican Regent, Inc.8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a2024-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087408
application number: ANDA087408
ndc (product): 0517-5601
ndc (product): 0517-5602
ndc (product): 0517-4201
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst16a63845-6619-293b-e063-6394a90a0a5c2024-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087408
application number: ANDA087408

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9877Hydroxyzine HydrochlorideHydroxyzine HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9877Hydroxyzine HydrochlorideHydroxyzine HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9878HydroxyzineHydroxyzineHenry Schein, Inc.ANDACurrent
0404-9878HydroxyzineHydroxyzineHenry Schein, Inc.ANDACurrent
0517-4201Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-4201Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-4201Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-5601Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-5601Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-5601Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-5602Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-5602Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-5602Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
52584-007HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-007HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-007HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-007HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-007HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-601HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-601HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-601HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-610HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-610HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-610HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent