FDA.reportPublic FDA data

Application 084301

Type
ANDA
Sponsor
TEVA

Application Products#

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

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
A084301-001DRALZINEHYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALApproved before 1982

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 UTC2022-09A084301-001DRALZINE25MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084301-001DRALZINE25MGTABLET / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A084301-001DRALZINE25MGTABLET / ORALApproved before 1982a50c72e98297…

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 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.51c293c1-70e7-48c7-8af1-a8b74312ed562026-09-08Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.6c40d818-77a9-492c-b9b6-d8a0fe8d67362026-08-27Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.dca82025-a4cd-4856-aa19-bdf091bf89732026-08-14Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackd2d98842-ff32-4a61-94e0-60e06919948f2026-08-14Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC58773e8c-b6bc-6bc6-e063-6294a90adc262026-08-07Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLCdb7500f3-f8a6-46b1-bb64-9727617a96432026-07-30Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMajor Pharmaceuticalsb6ccd35e-f69c-4eef-a456-905e030ae9112026-07-15Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENorthwind Health Company, LLC1275dd50-d97f-2e8f-e063-6394a90a4a672026-06-22Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC8b7e88ef-5edd-40df-8e43-e3f29970be582026-06-19Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.d61ffa06-8138-4a1d-9530-095a80d9c9ce2026-06-12Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.a70d20d6-23f0-477e-915c-678a867821752026-06-12Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.0d65e146-83e5-427f-ac06-04c0d8e72cea2026-06-09Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC43ce0ecb-6d62-44bf-8539-823ae03eb9f42026-06-03Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLCa1066707-2391-4918-8ded-600c017fde482026-05-18Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.438479d0-ff61-4008-a0fc-1ee44b97cf7f2026-05-07Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.f0db9c3c-d841-46f9-8409-9ffca83d7a972026-05-06Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENavinta LLCae5d85df-11a3-4952-ade2-596d57cdd9872026-04-21Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.669532c9-ba15-4f4b-95a8-13782deb35212026-04-03Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDESafecor Health, LLC66c5eaa4-a51a-464b-98ad-f094f32876dd2026-03-11Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.f3c806a4-b971-421c-bcb9-9979c6d7aaec2026-02-27Warnings, Adverse reactionsName fallback
generic name: HYDRALAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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