Home Applications 075155 Application 075155
Type ANDA
Sponsor LANNETT CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 60MG No No 002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 30MG No No 003 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 120MG No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075155-001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 1998-10-30 A075155-002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 2000-01-13 A075155-003 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2000-08-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 of 4 · 132 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 2022-10-28 04:53 UTC 2022-10 A075155-001 ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 1998-10-30 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A075155-002 ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 2000-01-13 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A075155-003 ISOSORBIDE MONONITRATE 120MG TABLET, EXTENDED RELEASE / ORAL AB RS 2000-08-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075155-001 ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 1998-10-30 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075155-002 ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 2000-01-13 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075155-003 ISOSORBIDE MONONITRATE 120MG TABLET, EXTENDED RELEASE / ORAL AB RS 2000-08-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075155-001 ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 1998-10-30 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075155-002 ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 2000-01-13 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075155-003 ISOSORBIDE MONONITRATE 120MG TABLET, EXTENDED RELEASE / ORAL AB RS 2000-08-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075155-001 ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 1998-10-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075155-002 ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 2000-01-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075155-003 ISOSORBIDE MONONITRATE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2000-08-04 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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 2 · 37 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE REMEDYREPACK INC. d01d4f0f-5164-4ea3-b772-72b97961c6fb 2026-07-31 Warnings, Adverse reactions Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Coupler LLC 55f240e1-3056-38cc-e063-6294a90a814e 2026-07-06 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE Cardinal Health 107, LLC 72b8a20c-5833-4765-a4b5-9066eaec6ea1 2026-06-26 Warnings, Adverse reactions Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE Major Pharmaceuticals 8cbb364a-bafe-454b-a53f-bd7cd69a5593 2026-05-27 Warnings, Adverse reactions Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE Torrent Pharmaceuticals Limited 0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c 2026-05-11 Warnings, Adverse reactions Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Genus Lifesciences Inc. 0d739bf3-0672-4504-9064-b39d6b200b47 2026-04-09 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE ANI Pharmaceuticals, Inc. 06839534-85b8-42aa-b0e3-079ed236be44 2026-03-27 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Shandong New Time Pharmaceutical Co., Ltd. cd953cfa-b6f5-4b82-afcc-52a57236b9d3 2026-01-06 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Northwind Health Company, LLC df5fd5e2-3a7b-5a5b-e053-2995a90a0dd3 2026-01-01 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Coupler LLC 46b3030d-f492-da9d-e063-6294a90a31b3 2025-12-24 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Chartwell RX, LLC b38f43c8-d02d-4aee-ab23-e898cbfadfbc 2025-12-02 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE isosorbide mononitrate ISOSORBIDE MONONITRATE Coupler LLC 3e0e013f-6887-fa72-e063-6294a90a18ca 2025-09-05 Warnings, Adverse reactions Name fallback brand name: isosorbide mononitrate generic name: ISOSORBIDE MONONITRATE isosorbide mononitrate ISOSORBIDE MONONITRATE Coupler LLC 3dffc84e-93e4-0005-e063-6294a90aa9ca 2025-09-04 Warnings, Adverse reactions Name fallback brand name: isosorbide mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Bryant Ranch Prepack cd60ded0-01d9-4a51-a8ad-cdfeb27d88fb 2025-08-26 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE isosorbide mononitrate ISOSORBIDE MONONITRATE OMNIVIUM PHARMACEUTICALS LLC. cdf01e14-778b-4b3f-8372-1c18f266fb98 2025-08-06 Warnings, Adverse reactions Name fallback brand name: isosorbide mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Edenbridge Pharmaceuticals LLC. 7443a5b6-6153-4227-870c-3c710f1f2174 2025-06-06 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Edenbridge Pharmaceuticals LLC. 0e3c4461-2e04-481f-a9e5-29f21cc71ec5 2025-06-06 Warnings, Adverse reactions Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE Coupler LLC 2d99893a-296a-134c-e063-6294a90ace3b 2025-02-07 Warnings, Adverse reactions Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE A-S Medication Solutions 5fd86c08-18de-43a2-9962-ab6cbf57d6c0 2025-01-17 Warnings, Adverse reactions Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE Isosorbide Mononitrate ISOSORBIDE MONONITRATE Golden State Medical Supply, Inc. 86be0e85-5337-bee4-e053-2a91aa0a8158 2024-11-11 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 · 68 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-575 isosorbide mononitrate isosorbide mononitrate Rebel Distributors Corp ANDA Current 21695-777 isosorbide mononitrate isosorbide mononitrate Rebel Distributors Corp ANDA Current 21695-837 isosorbide mononitrate isosorbide mononitrate Rebel Distributors Corp ANDA Current 43063-313 isosorbide mononitrate isosorbide mononitrate PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-313 isosorbide mononitrate isosorbide mononitrate PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-313 isosorbide mononitrate isosorbide mononitrate PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-313 isosorbide mononitrate isosorbide mononitrate PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-313 isosorbide mononitrate isosorbide mononitrate PD-Rx Pharmaceuticals, Inc. ANDA Current 43353-917 isosorbide mononitrate isosorbide mononitrate Aphena Pharma Solutions - Tennessee, LLC ANDA Current 43353-917 isosorbide mononitrate isosorbide mononitrate Aphena Pharma Solutions - Tennessee, LLC ANDA Current 50090-0787 isosorbide mononitrate isosorbide mononitrate A-S Medication Solutions ANDA Current 50090-2077 isosorbide mononitrate isosorbide mononitrate A-S Medication Solutions ANDA Current 50268-451 isosorbide mononitrate isosorbide mononitrate AvPAK ANDA Current 50268-451 isosorbide mononitrate isosorbide mononitrate AvPAK ANDA Current 50268-451 isosorbide mononitrate isosorbide mononitrate AvPAK ANDA Current 50268-452 isosorbide mononitrate isosorbide mononitrate AvPAK ANDA Current 50268-452 isosorbide mononitrate isosorbide mononitrate AvPAK ANDA Current 50268-452 isosorbide mononitrate isosorbide mononitrate AvPAK ANDA Current 50268-453 isosorbide mononitrate isosorbide mononitrate AvPAK ANDA Current 50268-453 isosorbide mononitrate isosorbide mononitrate AvPAK ANDA Current 50268-453 isosorbide mononitrate isosorbide mononitrate AvPAK ANDA Current 50436-3944 isosorbide mononitrate isosorbide mononitrate Unit Dose Services ANDA Current 55154-4785 isosorbide mononitrate isosorbide mononitrate Cardinal Health ANDA Current 55154-4785 isosorbide mononitrate isosorbide mononitrate Cardinal Health ANDA Current 55154-4785 isosorbide mononitrate isosorbide mononitrate Cardinal Health ANDA Current 55154-4786 isosorbide mononitrate isosorbide mononitrate Cardinal Health ANDA Current 55154-4786 isosorbide mononitrate isosorbide mononitrate Cardinal Health ANDA Current 55154-4786 isosorbide mononitrate isosorbide mononitrate Cardinal Health ANDA Current 55700-123 isosorbide mononitrate isosorbide mononitrate Lake Erie Medical DBA Quality Care Products LLC ANDA Current 62175-119 isosorbide mononitrate isosorbide mononitrate Lannett Company, Inc.. ANDA Current 62175-119 isosorbide mononitrate isosorbide mononitrate Lannett Company, Inc. ANDA Current 62175-119 isosorbide mononitrate isosorbide mononitrate Lannett Company, Inc. ANDA Current 62175-119 isosorbide mononitrate isosorbide mononitrate Lannett Company, Inc. ANDA Current 62175-128 isosorbide mononitrate isosorbide mononitrate Lannett Company, Inc.. ANDA Current 62175-128 isosorbide mononitrate isosorbide mononitrate Lannett Company, Inc. ANDA Current 62175-128 isosorbide mononitrate isosorbide mononitrate Lannett Company, Inc. ANDA Current 62175-128 isosorbide mononitrate isosorbide mononitrate Lannett Company, Inc. ANDA Current 62175-129 isosorbide mononitrate isosorbide mononitrate Lannett Company, Inc.. ANDA Current 62175-129 isosorbide mononitrate isosorbide mononitrate Lannett Company, Inc. ANDA Current 62175-129 isosorbide mononitrate isosorbide mononitrate Lannett Company, Inc. ANDA Current 62175-129 isosorbide mononitrate isosorbide mononitrate Lannett Company, Inc. ANDA Current 63629-1424 isosorbide mononitrate isosorbide mononitrate Bryant Ranch Prepack ANDA Current 63629-1424 isosorbide mononitrate isosorbide mononitrate Bryant Ranch Prepack ANDA Current 63629-1424 isosorbide mononitrate isosorbide mononitrate Bryant Ranch Prepack ANDA Current 63629-1823 isosorbide mononitrate isosorbide mononitrate Bryant Ranch Prepack ANDA Current 63629-1823 isosorbide mononitrate isosorbide mononitrate Bryant Ranch Prepack ANDA Current 67544-224 isosorbide mononitrate isosorbide mononitrate Aphena Pharma Solutions - Tennessee, LLC ANDA Current 67544-224 isosorbide mononitrate isosorbide mononitrate Aphena Pharma Solutions - Tennessee, LLC ANDA Current 67544-236 isosorbide mononitrate isosorbide mononitrate Aphena Pharma Solutions - Tennessee, LLC ANDA Current 67544-236 isosorbide mononitrate isosorbide mononitrate Aphena Pharma Solutions - Tennessee, LLC ANDA Current 68071-1926 isosorbide mononitrate isosorbide mononitrate NuCare Pharmaceuticals, Inc. ANDA Current 68071-3266 isosorbide mononitrate isosorbide mononitrate NuCare Pharmaceuticals, Inc. ANDA Current 68084-591 isosorbide mononitrate isosorbide mononitrate American Health Packaging ANDA Current 68084-591 Isosorbide Mononitrate Isosorbide Mononitrate American Health Packaging ANDA Current 68084-591 Isosorbide Mononitrate Isosorbide Mononitrate American Health Packaging ANDA Current 68084-591 Isosorbide Mononitrate Isosorbide Mononitrate American Health Packaging ANDA Current 68084-592 isosorbide mononitrate isosorbide mononitrate American Health Packaging ANDA Current 68084-592 Isosorbide Mononitrate Isosorbide Mononitrate American Health Packaging ANDA Current 68084-592 Isosorbide Mononitrate Isosorbide Mononitrate American Health Packaging ANDA Current 68084-592 Isosorbide Mononitrate Isosorbide Mononitrate American Health Packaging ANDA Current 68151-1420 isosorbide mononitrate isosorbide mononitrate Carilion Materials Management ANDA Current 68788-6863 isosorbide mononitrate isosorbide mononitrate Preferred Pharmaceuticals Inc. ANDA Current 70518-0009 isosorbide mononitrate isosorbide mononitrate REMEDYREPACK INC. ANDA Current 70518-2201 isosorbide mononitrate isosorbide mononitrate REMEDYREPACK INC. ANDA Current 70518-2201 isosorbide mononitrate isosorbide mononitrate REMEDYREPACK INC. ANDA Current 70518-2201 isosorbide mononitrate isosorbide mononitrate REMEDYREPACK INC. ANDA Current 70518-3132 isosorbide mononitrate isosorbide mononitrate REMEDYREPACK INC. ANDA Current 70934-573 isosorbide mononitrate isosorbide mononitrate Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 39459 SUPPL 2014-10-24 8543 SUPPL 2014-10-24 8542 ORIG 1998-10-30