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 4 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrALAZINE hydrochlorideHYDRALAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.3f5f1204-d289-40e9-be84-a29352f64bfb2024-04-10Warnings, Adverse reactionsName fallback
brand name: HydrALAZINE hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst15b0f03b-b5a2-c49d-e063-6394a90a5b152024-04-09Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc2638ae6-a210-490f-8389-bbed6a3229c52024-04-03Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack8224aa3d-b1b9-40df-93fd-a91c6a1588982024-02-20Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackbc37cf50-b18d-467e-bf67-3270faa8332e2024-02-05Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackd5b0165e-9823-470a-8ed0-5c4c8722369d2024-02-05Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack4d1594dc-376b-44bd-8c0e-5de731dfb7f92024-02-02Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9949407f-e410-7f47-e053-2995a90a73692024-01-30Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack18dd864f-1e27-4c98-8f21-eaded77a3ed62024-01-11Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepacke6d4b15e-1407-4783-94e4-9971dea682212024-01-11Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack36499d4b-bcaf-4b49-aa2a-10c3e34550d02024-01-11Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack4985994c-23ab-4409-bab6-5a17db767f132024-01-11Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack162a0c00-4db8-4f8d-9686-be2f8449abd82024-01-11Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack914d5b62-6f9b-4665-8562-689367c362302023-12-14Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackd4509f69-e60e-4440-957b-5c27144803352023-11-27Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutionse617023e-b060-4db9-a97e-e2b11a37901e2023-08-28Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack62475f78-5410-43c2-a11d-54a8363c3ae12023-07-25Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLC7979c865-737d-d999-e053-2a91aa0abc5e2023-05-16Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HydrALAZINE hydrochlorideHYDRALAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLCd89d981d-64cf-7321-e053-2995a90aab4a2023-05-03Warnings, Adverse reactionsName fallback
brand name: HydrALAZINE hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLCdd2cd8a1-7bdd-05e4-e053-2995a90ad3662023-05-02Warnings, 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.