FDA.reportPublic FDA data

Application 088529

Type
ANDA
Sponsor
QUANTUM PHARMICS

Application Products#

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

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
A088529-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-2284e616aacf4f…
2026-08-18 06:07:402026-07A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-223f01610625f2…
2019-09-15 20:21 UTC2019-09A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088529-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL1985-10-22f41ea6bd6efb…

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 7 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LPd79be126-39cd-4dbb-ad88-0e4c18109dda2024-05-01Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsc59f24b5-0527-423a-ab14-db1ba1f7763f2024-04-16Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack2562692e-e9cc-4f81-bdc9-47b7d42337582024-04-05Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackf6f688d0-cb13-40af-a65f-480c37334e372024-04-03Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack1c7d31fb-5e3c-456e-be6c-a3baafe60c372024-04-02Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsc2bce6a4-9feb-4816-a6d8-151e8ef3314d2024-03-11Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEMedsource Pharmaceuticals13172e1e-2b62-8a67-e063-6394a90a30102024-03-07Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions3946db7c-dc2d-4329-b9ac-f003d8c6d3e12024-01-05Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionse83de74d-b2e0-45c5-b072-170a96216d3a2024-01-04Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions80e60583-76d3-4e65-8581-4cdaff7cd1c12023-10-23Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEChartwell RX, LLC4590101d-7fb2-478b-acc5-bc9bdbb38ca92023-10-11Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd618157e-f43f-4b31-ba5b-8a13a94885bc2023-09-18Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions2e346b0c-9407-4346-82c2-d9755cbcd8b02023-09-11Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions49ee4ecf-b2c0-4301-89da-111e4d8531682023-09-11Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions46266803-0905-4ae2-9d17-dbf4c2a081812023-09-07Warnings, Adverse reactionsName fallback
brand name: HydrOXYzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions3d5d3ebf-e57e-4ed1-be97-d4b299fb738d2023-09-07Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions3d2e63c6-993c-42b9-91a0-616246789a7b2023-09-07Warnings, Adverse reactionsName fallback
brand name: HydrOXYzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions92d8cc57-7e3a-4217-9160-e1b56db5570e2023-05-09Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDELannett Company, Inc.a4fb61ae-aad6-4bd6-83fc-8b227f175df92023-01-24Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC8e954579-b0f5-4ce3-bade-0b9b972f6f8b2023-01-23Warnings, 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.