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 5 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDECadila Pharmaceuticals Limited3a7562a8-2f67-4411-ac4a-ab7924193e822022-12-29Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLCc3797028-c625-4f70-ae69-8a5f6f23f1b82022-08-09Warnings, Adverse reactionsName fallback
brand name: hydrALAZINE Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLC8223c44a-73a9-4da5-a468-d1d8bdb0bbd62022-05-18Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDERadha Pharmaceuticals, Inc.149fa857-30ad-451d-b6e2-0000483ccc972021-03-12Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEScieGen Pharmaceuticals, Inc.500b7f76-5f4e-4e7d-85c3-18b9f66d75042021-03-04Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEExelan Pharmaceuticals Inc.811831f9-a844-463a-874d-fb8407659f0b2020-09-04Warnings, Adverse reactionsName fallback
brand name: HydrALAZINE Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP63f388e0-9f3d-4902-990c-9a105aa098ad2020-09-01Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LPdfd60a79-2a30-41e6-b000-a144730099a82019-10-01Warnings, Adverse reactionsName fallback
brand name: HydrALAZINE Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP48cf71dd-19dc-4239-9117-ebcf9731a45d2019-10-01Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAmerican Regent, Inc.17210abc-58f6-442e-8ff2-7971333c82f62019-05-06Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAscend Laboratories, LLCe7bfec3d-5222-4a26-8f99-6c2a28e14aa62017-12-28Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCbfbd5960-ae6b-46f5-adfa-e330d7a21dfa2017-12-21Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC921c8693-84c2-4313-a2a6-ab3be637d5542016-07-14Warnings, Adverse reactionsName fallback
brand name: HydrALAZINE Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd9892176-d4a6-4edb-92b9-5f56243f3d222016-06-13Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.ddbbdb09-3202-42d7-bbb0-08331dde2f542016-02-29Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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