FDA.reportPublic FDA data

Application 207120

Type
ANDA
Sponsor
NUVO PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

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 UTC2019-12A207120-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2017-03-2974a2ff9319b5…
2019-12-14 00:12 UTC2019-12A207120-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2017-03-293f01610625f2…
2019-09-15 20:21 UTC2019-09A207120-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2017-03-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A207120-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2017-03-29ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A207120-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A207120-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207120-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207120-001AB1ea99ee380514…

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 1 of 8 · 147 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDESt Mary's Medical Park Pharmacy9ef6a4b7-362d-61b4-e053-2995a90a0ebb2026-07-28Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca2026-07-24Warnings, Adverse reactionsName fallback
brand name: HydrOXYzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy30b6f7b3-b620-961a-e063-6394a90a487b2026-07-23Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.ca67c061-c743-4ebb-a9d5-ece4880606632026-07-22Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEAPOZEAL PHARMACEUTICALS INC87d4bbff-0498-4c26-86cb-7ce173afa0b62026-07-21Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsbe6a2f09-c0f3-44e2-aac3-37e3702b93f02026-07-21Warnings, Adverse reactionsName fallback
brand name: HydrOXYzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDECardinal Health 107, LLCb4d274ce-d616-4835-80ce-76270524ed362026-07-20Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEMajor Pharmaceuticals7f76580c-96a0-4b56-8986-ff5488bb98692026-07-15Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.bb4a7d22-2f42-4e9f-bf98-cee43ed14d502026-07-15Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Incc8b441bf-a03e-47b3-8f06-c347f5ca4b702026-07-15Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.b6189074-e199-4f58-a78d-c04f131c13d92026-07-10Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.aa9523e0-c95d-4213-b213-96170d8555362026-07-10Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC5648abce-f20e-717c-e063-6294a90a88ac2026-07-10Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack66be7bde-d2bd-4c65-bde9-0fb9f5be093f2026-07-02Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LP83e8d60d-36fd-4223-b50c-e6615045352a2026-07-01Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEUnit Dose Solutions, Inc.5506e802-0efc-a845-e063-6394a90aad0e2026-06-24Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAmerican Health Packaging47bda4fe-ddb7-4140-900a-970373cc7acc2026-06-23Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackf84e3365-57d2-4904-9275-96600f8d74c72026-06-22Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDESaptalis Pharmaceuticals, LLC.9ab23881-334c-474d-9d93-25ea225548dc2026-06-16Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEMajor Pharmaceuticals7534a3bb-b4cd-415f-8612-53b37dc6d55f2026-06-15Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE