FDA.reportPublic FDA data

Application 074476

Type
ANDA
Sponsor
ROXANE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYUREAHYDROXYUREACAPSULE;ORAL500MGNoNo

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
A074476-001HYDROXYUREAHYDROXYUREA500MGCAPSULE / ORAL1995-08-18

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A074476-001HYDROXYUREA500MGCAPSULE / ORAL1995-08-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074476-001HYDROXYUREA500MGCAPSULE / ORAL1995-08-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074476-001HYDROXYUREA500MGCAPSULE / ORAL1995-08-18a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydroxyureaHYDROXYUREAMajor Pharmaceuticalse76fd60e-7644-48c5-9857-3608a045000b2026-05-27Warnings, Adverse reactionsName fallback
brand name: Hydroxyurea
generic name: HYDROXYUREA
HydroxyureaHYDROXYUREAPar Health USA, LLC9e1bdd4b-043a-4cf6-b1ff-8de49e02b7a62026-05-07Warnings, Adverse reactionsName fallback
brand name: Hydroxyurea
generic name: HYDROXYUREA
HydroxyureaHYDROXYUREAAmerican Health Packagingc84a2241-6c05-480f-8a5b-049e08c27d732026-03-02Warnings, Adverse reactionsName fallback
brand name: Hydroxyurea
generic name: HYDROXYUREA
XROMIHYDROXYUREANova Laboratories, Ltd.4b37d336-86da-4363-aef1-34a7d3ba973b2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HYDROXYUREA
HYDREAHYDROXYUREAH2-Pharma LLC6053c775-68de-45e4-9af9-33b18fd0e1402026-01-26Warnings, Adverse reactionsName fallback
generic name: HYDROXYUREA
DROXIAHYDROXYUREAH2-Pharma LLCa9494409-3571-4a81-9ad3-15ef7cb636a22026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HYDROXYUREA
SiklosHYDROXYUREAMedunik76957c0d-0f98-4376-bb06-eee651adc09d2026-01-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HYDROXYUREA
HYDROXYUREAHYDROXYUREACoupler LLC44fd5379-5fb0-ff62-e063-6294a90ac7922025-12-02Warnings, Adverse reactionsName fallback
brand name: HYDROXYUREA
generic name: HYDROXYUREA
HYDROXYUREAHYDROXYUREAAvKARE862583ff-6d5c-3f7d-e3bd-352fb04009282025-10-15Warnings, Adverse reactionsName fallback
brand name: HYDROXYUREA
generic name: HYDROXYUREA
HYDREAHYDROXYUREAWaylis Therapeutics LLC8d41152f-a98a-4abc-afdf-a909012434a02025-09-15Warnings, Adverse reactionsName fallback
generic name: HYDROXYUREA
DROXIAHYDROXYUREAWaylis Therapeutics LLC4ad13dc6-a2ab-4308-96b3-7c642c92cc232025-09-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HYDROXYUREA
HYDROXYUREAHYDROXYUREAGolden State Medical Supply, Inc.1b42f2b4-3880-e7a9-e063-6294a90a5fd02024-11-25Warnings, Adverse reactionsName fallback
brand name: HYDROXYUREA
generic name: HYDROXYUREA
HYDROXYUREAHYDROXYUREALeading Pharma, LLC4c4e1c2f-2143-44f3-8825-aeba42e755e42024-10-29Warnings, Adverse reactionsName fallback
brand name: HYDROXYUREA
generic name: HYDROXYUREA
HYDROXYUREAHYDROXYUREASomerset Therapeutics, LLC9752a347-b42c-44d5-8fd1-c538f7f239dc2024-09-23Warnings, Adverse reactionsName fallback
brand name: HYDROXYUREA
generic name: HYDROXYUREA
HYDROXYUREAHYDROXYUREATeva Pharmaceuticals USA, Inc.b9514ae5-79ae-4cc2-9d7f-c8f7806d16942024-05-30Warnings, Adverse reactionsName fallback
brand name: HYDROXYUREA
generic name: HYDROXYUREA
HYDROXYUREAHYDROXYUREAQilu Pharmaceutical Co., Ltd.4cd244d4-bd4a-41c8-b072-c2135787d4122024-04-30Warnings, Adverse reactionsName fallback
brand name: HYDROXYUREA
generic name: HYDROXYUREA

Reported adverse events (FAERS/openFDA)#

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