Application 210918

Type
ANDA
Sponsor
RICONPHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL30MGNoNo
002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL60MGNoNo
003ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL120MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210918-001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05
A210918-002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05
A210918-003ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A210918-001AB
A210918-002AB
A210918-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-051e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210918-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210918-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210918-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210918-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210918-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210918-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210918-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210918-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210918-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210918-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210918-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210918-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210918-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210918-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210918-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210918-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210918-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210918-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210918-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210918-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210918-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210918-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210918-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210918-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210918-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210918-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210918-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210918-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210918-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210918-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210918-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210918-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210918-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210918-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210918-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210918-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210918-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210918-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210918-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210918-001AB11e350fbaab3a…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isosorbide MononitrateISOSORBIDE MONONITRATENorthwind Health Company, LLCdf5fd5e2-3a7b-5a5b-e053-2995a90a0dd32026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
ndc (product): 51655-922
Isosorbide MononitrateISOSORBIDE MONONITRATEGolden State Medical Supply, Inc.86be0e85-5337-bee4-e053-2a91aa0a81582024-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
ndc (product): 51407-209
ndc (product): 51407-210
ndc (product): 51407-208
Isosorbide MononitrateISOSORBIDE MONONITRATEAphena Pharma Solutions - Tennessee, LLC17525ff2-9ec0-15a1-e063-6394a90ab7622024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEBryant Ranch Prepack441ddd35-6cb8-44d0-8009-1635390ede832024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
ndc (product): 71335-2194
Isosorbide MononitrateISOSORBIDE MONONITRATEAphena Pharma Solutions - Tennessee, LLC0af6c67f-919d-4515-8074-f6c3aaa835b52024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEAphena Pharma Solutions - Tennessee, LLC18cf36bc-e73f-4274-b381-c2f2aa02f57d2024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEA-S Medication Solutionsadcca9b8-0505-4bbc-81ab-05efc7407b6b2024-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEA-S Medication Solutions4da5a0ac-574d-48ea-80ba-55344bfefb912023-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
ndc (product): 50090-5686
Isosorbide MononitrateISOSORBIDE MONONITRATEIngenus Pharmaceuticals, LLCc950760f-0e32-483f-96f2-eecaf057c0ec2023-10-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
ndc (product): 50742-175
ndc (product): 50742-176
ndc (product): 50742-177
Isosorbide MononitrateISOSORBIDE MONONITRATEBryant Ranch Prepack96420729-2bc7-4d03-9c51-f786ea6789982023-10-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
ndc (product): 71335-2192

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5572Isosorbide MononitrateIsosorbide MononitrateA-S Medication SolutionsANDACurrent
50090-5686Isosorbide MononitrateIsosorbide MononitrateA-S Medication SolutionsANDACurrent
50090-5686Isosorbide MononitrateIsosorbide MononitrateA-S Medication SolutionsANDACurrent
50742-175Isosorbide MononitrateIsosorbide MononitrateIngenus Pharmaceuticals, LLCANDACurrent
50742-175Isosorbide MononitrateIsosorbide MononitrateIngenus Pharmaceuticals, LLCANDACurrent
50742-175Isosorbide MononitrateIsosorbide MononitrateIngenus Pharmaceuticals, LLCANDACurrent
50742-175Isosorbide MononitrateIsosorbide MononitrateIngenus Pharmaceuticals, LLCANDACurrent
50742-176Isosorbide MononitrateIsosorbide MononitrateIngenus Pharmaceuticals, LLCANDACurrent
50742-176Isosorbide MononitrateIsosorbide MononitrateIngenus Pharmaceuticals, LLCANDACurrent
50742-176Isosorbide MononitrateIsosorbide MononitrateIngenus Pharmaceuticals, LLCANDACurrent
50742-176Isosorbide MononitrateIsosorbide MononitrateIngenus Pharmaceuticals, LLCANDACurrent
50742-177Isosorbide MononitrateIsosorbide MononitrateIngenus Pharmaceuticals, LLCANDACurrent
50742-177Isosorbide MononitrateIsosorbide MononitrateIngenus Pharmaceuticals, LLCANDACurrent
50742-177Isosorbide MononitrateIsosorbide MononitrateIngenus Pharmaceuticals, LLCANDACurrent
50742-177Isosorbide MononitrateIsosorbide MononitrateIngenus Pharmaceuticals, LLCANDACurrent
51407-208Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply Inc.ANDACurrent
51407-208Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply, Inc.ANDACurrent
51407-208Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply, Inc.ANDACurrent
51407-208Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply, Inc.ANDACurrent
51407-208Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply, Inc.ANDACurrent
51407-209Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply Inc.ANDACurrent
51407-209Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply, Inc.ANDACurrent
51407-209Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply, Inc.ANDACurrent
51407-209Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply, Inc.ANDACurrent
51407-209Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply, Inc.ANDACurrent
51407-210Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply Inc.ANDACurrent
51407-210Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply, Inc.ANDACurrent
51407-210Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply, Inc.ANDACurrent
51407-210Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply, Inc.ANDACurrent
51407-210Isosorbide MononitrateIsosorbide MononitrateGolden State Medical Supply, Inc.ANDACurrent
51655-922Isosorbide MononitrateIsosorbide MononitrateNorthwind PharmaceuticalsANDACurrent
70518-3585Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
71335-2192Isosorbide MononitrateIsosorbide MononitrateBryant Ranch PrepackANDACurrent
71335-2194Isosorbide MononitrateIsosorbide MononitrateBryant Ranch PrepackANDACurrent
71610-321Isosorbide MononitrateIsosorbide MononitrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-337Isosorbide MononitrateIsosorbide MononitrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-338Isosorbide MononitrateIsosorbide MononitrateAphena Pharma Solutions - Tennessee, LLCANDACurrent