Home Applications 086223 Application 086223
Type ANDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A086223-001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A086223-001 AB
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 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A086223-001 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 1988-01-07 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0615-7902 Isosorbide Dinitrate Isosorbide Dinitrate NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0781-1556 Isosorbide Dinitrate Isosorbide Dinitrate Sandoz Inc. ANDA Current 0781-1556 Isosorbide Dinitrate Isosorbide Dinitrate Sandoz Inc. ANDA Current 0781-1556 Isosorbide Dinitrate Isosorbide Dinitrate Sandoz Inc. ANDA Current 0781-1556 Isosorbide Dinitrate Isosorbide Dinitrate Sandoz Inc. ANDA Current 0781-1556 Isosorbide Dinitrate Isosorbide Dinitrate Sandoz Inc ANDA Current 55154-5406 Isosorbide Dinitrate Isosorbide Dinitrate Cardinal Health ANDA Current 68001-225 Isosorbide Dinitrate Isosorbide Dinitrate BluePoint Laboratories ANDA Current 68001-225 Isosorbide Dinitrate Isosorbide Dinitrate BluePoint Laboratories ANDA Current 70518-0063 Isosorbide Dinitrate Isosorbide Dinitrate REMEDYREPACK INC. ANDA Current 70518-0063 Isosorbide Dinitrate Isosorbide Dinitrate REMEDYREPACK INC. ANDA Current 70518-0063 Isosorbide Dinitrate Isosorbide Dinitrate REMEDYREPACK INC. ANDA Current 70518-0063 Isosorbide Dinitrate Isosorbide Dinitrate REMEDYREPACK INC. ANDA Current 70518-0063 Isosorbide Dinitrate Isosorbide Dinitrate REMEDYREPACK INC. ANDA Current 70518-0063 Isosorbide Dinitrate Isosorbide Dinitrate REMEDYREPACK INC. ANDA Current 70518-0063 Isosorbide Dinitrate Isosorbide Dinitrate REMEDYREPACK INC. ANDA Current