FDA.reportPublic FDA data

Application 207122

Type
ANDA
Sponsor
NUVO PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A207122-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2017-03-2974a2ff9319b5…
2019-12-14 00:12 UTC2019-12A207122-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2017-03-293f01610625f2…
2019-09-15 20:21 UTC2019-09A207122-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2017-03-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A207122-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2017-03-29ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A207122-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A207122-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207122-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207122-001AB1ea99ee380514…

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 2 of 8 · 147 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy1767a886-ec92-39fb-e063-6294a90a12492026-06-03Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDECardinal Health 107, LLC157fbedc-b65d-455f-adb5-e7554282e0332026-06-03Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.534a6a49-23df-d65e-e063-6294a90a1a122026-06-02Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.52fb8616-7d4e-9c37-e063-6294a90a11122026-05-29Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDECoupler LLC519e54e0-a613-e7b3-e063-6294a90a44522026-05-12Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.413a39ce-98d6-40f5-9048-ad464e98de442026-05-11Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.7edd582c-039c-4bdc-bf8a-61eac8a5a9a02026-05-11Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Incl63fdf791-1a58-45ba-8ef2-15b80bb24f232026-05-11Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEProficient Rx LPca843456-0c93-41e8-9bbc-9cd92447f0922026-05-01Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDECoupler LLC508848a5-017c-dd3e-e063-6294a90a456b2026-04-28Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDERedpharm Drug4fb58637-dc30-c4dd-e063-6394a90a8bbe2026-04-18Warnings, Adverse reactionsName fallback
brand name: HydrOXYzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4cd84205-6a33-db48-e063-6394a90a91822026-04-16Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.f6ad4729-b291-42c4-8483-99385d8043db2026-04-09Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEKesin Pharma4b094d1b-97b2-6ca6-e063-6294a90a24372026-03-10Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAurobindo Pharma Limited9de2de56-614f-4294-8794-d30758cf5f702026-03-03Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack56b49e5c-bb8a-46cd-873c-3c743d1653a42026-02-17Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.71eea118-395c-4559-aed5-900b635674b82026-02-12Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc4aa896b1-4fd5-513e-e063-6294a90ab9502026-02-12Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions1350964e-663e-4a50-8c4c-cda371a694a02026-02-04Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS19fe26a9-eb1a-4c5b-a5e4-65223ee56ad12026-02-02Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE