FDA.reportPublic FDA data

Application 086243

Type
ANDA
Sponsor
HERITAGE PHARMS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog.

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 · 99 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMajor Pharmaceuticalsb6ccd35e-f69c-4eef-a456-905e030ae9112026-07-15Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENorthwind Health Company, LLC1275dd50-d97f-2e8f-e063-6394a90a4a672026-06-22Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC8b7e88ef-5edd-40df-8e43-e3f29970be582026-06-19Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.d61ffa06-8138-4a1d-9530-095a80d9c9ce2026-06-12Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.a70d20d6-23f0-477e-915c-678a867821752026-06-12Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.0d65e146-83e5-427f-ac06-04c0d8e72cea2026-06-09Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4671cefa-4468-4116-ba40-3d3b0f581ea12026-06-09Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC43ce0ecb-6d62-44bf-8539-823ae03eb9f42026-06-03Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLCa1066707-2391-4918-8ded-600c017fde482026-05-18Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.438479d0-ff61-4008-a0fc-1ee44b97cf7f2026-05-07Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.f0db9c3c-d841-46f9-8409-9ffca83d7a972026-05-06Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENavinta LLCae5d85df-11a3-4952-ade2-596d57cdd9872026-04-21Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.dca82025-a4cd-4856-aa19-bdf091bf89732026-04-14Warnings, Adverse reactionsName fallback
brand name: hydrALAZINE Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackdb138daf-2d2d-4730-a621-a1bd209d5b9f2026-04-03Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
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
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDESafecor Health, LLC66c5eaa4-a51a-464b-98ad-f094f32876dd2026-03-11Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.6c40d818-77a9-492c-b9b6-d8a0fe8d67362026-03-09Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.f3c806a4-b971-421c-bcb9-9979c6d7aaec2026-02-27Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC4aa1b3e8-9389-fe2c-e063-6294a90a7fb92026-02-12Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.89afc8ef-27c4-489a-81de-3f8f65f6bbb82026-02-09Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE