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 3 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECamber Pharmaceuticals, Inc.5da36930-d3da-4b5c-9e22-2b141bc01a9c2025-03-13Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEBaxter Healthcare Corporationf1a10203-f027-4f9c-8dd6-907c6db24d472025-03-10Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC2e9688ef-781c-aead-e063-6294a90a7bca2025-02-20Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDECoupler LLC2df51a19-a39a-0ec8-e063-6394a90a147c2025-02-12Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP775e99c4-e18d-4648-a0e3-8709950249ff2025-02-01Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst94530e4d-b1c0-6171-e053-2a95a90a05fa2025-01-08Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack7ae650f7-a481-4637-a9a2-9bda43a5a2882024-12-24Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a862321d-ebc1-7676-e053-2995a90a58612024-12-17Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackff2c4d1e-33ee-40d7-955b-d736f0559f392024-12-03Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack10f3e76e-9bba-4151-89fb-90d823a0a68c2024-11-08Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAmerican Health Packaging2e82655e-8435-46fa-b734-8e7c6e8034532024-09-23Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMacleods Pharmaceuticals Limitedf9f56326-6d72-47d3-89ac-3625b8a6d7132024-09-06Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsf07abdec-6d94-45b6-be1b-10a898ea28c22024-08-12Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutions8ade1ffe-3738-4aa1-b9c7-59f7290600b92024-08-07Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutionsa8194ac4-02d5-4aa1-b4e4-a3759f6f64b52024-08-07Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.3b61d1b0-c699-67a8-e054-00144ff88e882024-07-16Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4b7d3378-86f8-0a5f-e054-00144ff8d46c2024-07-15Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA37ba0233-ed75-498a-a067-6220da5736532024-05-24Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEModavar Pharmaceuticals LLCa456bc34-0c79-44f4-9119-50028a978f5f2024-05-14Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECivica, Inc.ffa483a4-de2a-4d42-ad27-afacd37f28e42024-04-28Warnings, 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.