Home Applications 075361 Application 075361
Type ANDA
Sponsor HIKMA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET;ORAL 20MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A075361-001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05
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 · 43 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 2026-09-14 22:38:34 2026-08 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 2000-10-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 2000-10-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 2000-10-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 2000-10-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075361-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL 2000-10-05 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 2 of 2 · 37 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE NCS HealthCare of KY, LLC dba Vangard Labs ba6120c8-c885-4cfa-b68e-9eee7a3bad6d 2024-08-13 Warnings, Adverse reactions Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE NCS HealthCare of KY, LLC dba Vangard Labs 63dc518f-4f86-4820-98c2-5de8aed09a4b 2024-08-13 Warnings, Adverse reactions Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE NuCare Pharmaceuticals,Inc. 65935a15-a023-1941-e053-2991aa0a5eb4 2024-06-06 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Aphena Pharma Solutions - Tennessee, LLC 17525ff2-9ec0-15a1-e063-6394a90ab762 2024-04-30 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Bryant Ranch Prepack 441ddd35-6cb8-44d0-8009-1635390ede83 2024-04-03 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Aphena Pharma Solutions - Tennessee, LLC 0af6c67f-919d-4515-8074-f6c3aaa835b5 2024-02-06 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Aphena Pharma Solutions - Tennessee, LLC 18cf36bc-e73f-4274-b381-c2f2aa02f57d 2024-02-06 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE A-S Medication Solutions adcca9b8-0505-4bbc-81ab-05efc7407b6b 2024-01-23 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE A-S Medication Solutions 4da5a0ac-574d-48ea-80ba-55344bfefb91 2023-12-09 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE A-S Medication Solutions 44a0f691-b826-4580-ab2d-b5d1cc99e283 2023-11-09 Warnings, Adverse reactions Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Ingenus Pharmaceuticals, LLC c950760f-0e32-483f-96f2-eecaf057c0ec 2023-10-27 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Bryant Ranch Prepack 96420729-2bc7-4d03-9c51-f786ea678998 2023-10-26 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE A-S Medication Solutions 5a8164a3-56e2-4b9b-8718-0423b4b4958f 2023-09-05 Warnings, Adverse reactions Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE Aurobindo Pharma Limited 55810c9d-1140-40b8-a297-210a84afc05a 2022-11-11 Warnings, Adverse reactions Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Actavis Pharma, Inc. ae8f74f0-e600-4452-8557-958b603e2709 2022-10-01 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE isosorbide mononitrate ISOSORBIDE MONONITRATE Lannett Company, Inc. bf9e7e35-7707-42a0-88d6-6292fa52bbfa 2020-06-05 Warnings, Adverse reactions Name fallback brand name: isosorbide mononitrate generic name: ISOSORBIDE MONONITRATE isosorbide mononitrate ISOSORBIDE MONONITRATE Proficient Rx LP f871dfa7-219f-4704-8e4d-215caeb7408d 2019-11-01 Warnings, Adverse reactions Name fallback brand name: isosorbide mononitrate generic name: ISOSORBIDE MONONITRATE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0143-1333 Isosorbide Mononitrate Isosorbide Mononitrate West-ward Pharmaceutical Corp ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8631 ORIG 2000-10-05