FDA.reportPublic FDA data

Application 040842

Type
ANDA
Sponsor
NORTHSTAR HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL25MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 6 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEEpic Pharma, LLC82b015dc-999c-46a4-bcaa-a4c81a193b682025-01-31Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC09092888-0c18-501d-e063-6294a90aad672024-12-31Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEAsclemed USA, Inc.4f3266f4-00a6-4c0c-bff2-e606913de8942024-12-17Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDESunrise Pharmaceutical, Inc.94561525-a565-4193-b64d-e1459ab056782024-12-09Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEChartwell RX, LLC934afb42-fee8-415b-8090-2265bb299afe2024-10-28Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINEAmneal Pharmaceuticals LLC89901966-724b-4773-98b8-ea663ceabd532024-10-25Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEChartwell RX, LLC53b2d731-f38a-47c0-9e5c-abd3b45e2fe12024-10-22Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.99995bdb-a35f-7753-e053-2995a90a683c2024-10-15Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.79f38cc2-f72f-3f30-e053-2991aa0ac5402024-09-25Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC7b6ebf69-77d5-434f-81a4-3d5587fd431e2024-08-29Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack3f5be725-8ade-4889-b6b1-7d45f54585462024-08-20Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack9714d429-e7f6-4adf-b3f0-cb21e6edb4332024-08-15Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a8af7dd0-fef8-5c39-e053-2a95a90ae11a2024-07-17Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1bf88820-e5f9-06e7-e063-6294a90a80ad2024-06-28Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.714a26a1-371f-ef23-e053-2a95a90a6af62024-06-10Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack4b8614d9-335c-4141-aaed-445c604ba08c2024-06-10Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAmerican Regent, Inc.8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a2024-06-05Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC19b08f92-da63-021f-e063-6394a90a16e22024-05-30Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst16a63845-6619-293b-e063-6394a90a0a5c2024-05-28Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC138ec5c1-bb06-2a82-e063-6394a90ab42b2024-05-17Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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