FDA.reportPublic FDA data

Application 088124

Type
ANDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SORBITRATEISOSORBIDE DINITRATETABLET;ORAL30MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A088124-001SORBITRATEISOSORBIDE DINITRATE30MGTABLET / ORAL1990-08-21

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A088124-001SORBITRATE30MGTABLET / ORAL1990-08-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088124-001SORBITRATE30MGTABLET / ORAL1990-08-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088124-001SORBITRATE30MGTABLET / ORAL1990-08-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A088124-001SORBITRATE30MGTABLET / ORAL1990-08-21a50c72e98297…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isosorbide DinitrateISOSORBIDE DINITRATEPar Health USA, LLC6df6a2fa-c56c-4eb6-a485-c16585420eb02026-07-31Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide DinitrateISOSORBIDE DINITRATEPar Health USA, LLC3d6164d7-3083-41c5-a6a6-7e144fe29f7d2026-07-22Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide DinitrateISOSORBIDE DINITRATECardinal Health 107, LLC5f585259-59ed-4648-b562-164f3746c8212026-05-19Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide DinitrateISOSORBIDE DINITRATEMajor Pharmaceuticals6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb2026-03-13Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide DinitrateISOSORBIDE DINITRATEAvPAK0e5842f2-74f6-1f02-01bc-07578bd3b3932026-02-10Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEREMEDYREPACK INC.829ed058-333f-453c-9f0e-9202e03acf972026-01-08Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide DinitrateISOSORBIDE DINITRATEGolden State Medical Supply, Inc.7f860fbd-f130-4652-e053-2991aa0a402e2026-01-08Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEAdvagen Pharma Ltdb166eb5b-bad8-4663-9c05-1c43539dab2c2026-01-05Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide DinitrateISOSORBIDE DINITRATEHikma Pharmaceuticals USA Inc.f0b9b320-0bf8-4342-b654-135ccb6755c22025-12-05Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide DinitrateISOSORBIDE DINITRATEAmerican Health Packaging5c94ecc0-fcaa-4af3-82c2-ff124f2df3e12025-10-15Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide dinitrateISOSORBIDE DINITRATENorthstar Rx LLC246c749d-aa28-44ce-8d42-984660afff2a2025-08-21Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide DinitrateISOSORBIDE DINITRATEBryant Ranch Prepack73a1e6c0-71d0-4ba1-bbca-c067479e487d2024-10-08Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide dinitrateISOSORBIDE DINITRATEBluePoint Laboratoriesf1d52e9a-8de1-61db-e053-2a95a90aae502024-09-17Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide dinitrateISOSORBIDE DINITRATEZydus Pharmaceuticals (USA) Inc.16818b32-ee5e-4e07-b848-31e892c4b98a2024-08-08Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEProficient Rx LP1cf9b6dd-9d4e-4ea1-95ae-e9e46a3d1b202024-08-01Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEProficient Rx LP33d14f59-3ae8-4414-b826-06274cf0f3d92024-07-01Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide DinitrateISOSORBIDE DINITRATESandoz Inc.71fdd147-a987-40b6-9f07-82d56525ceb82024-02-01Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide dinitrateISOSORBIDE DINITRATEZydus Lifesciences Limited5b0db8af-bcf9-458f-b752-420130cba4282023-11-07Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATEISOSORBIDE DINITRATENCS HealthCare of KY, LLC dba Vangard Labs74a7f767-fa2f-4640-be24-34a8a91282172023-05-22Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE
Isosorbide DinitrateISOSORBIDE DINITRATEOceanside Pharmaceuticals723d9f78-9d77-4575-af27-1aa117e6b8d72020-03-02Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE DINITRATE

Reported adverse events (FAERS/openFDA)#

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