Home Applications 205103 Application 205103
Type NDA
Sponsor GENUS LIFESCIENCES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 YOSPRALA ASPIRIN; OMEPRAZOLE TABLET, DELAYED RELEASE;ORAL 81MG;40MG Yes No 002 YOSPRALA ASPIRIN; OMEPRAZOLE TABLET, DELAYED RELEASE;ORAL 325MG;40MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205103-001 YOSPRALA ASPIRIN; OMEPRAZOLE 81MG;40MG TABLET, DELAYED RELEASE / ORAL RLD 2016-09-14 N205103-002 YOSPRALA ASPIRIN; OMEPRAZOLE 325MG;40MG TABLET, DELAYED RELEASE / ORAL RLD 2016-09-14
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205103-001 9987231 2033-01-02 U-2324 2018-07-03 N205103-001 9539214 2033-03-13 U-1902 2017-01-27 N205103-002 9987231 2033-01-02 U-2324 2018-07-03 N205103-002 9539214 2033-03-13 U-1902 2017-01-27
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 3 of 3 · 88 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 N205103-001 YOSPRALA 81MG;40MG TABLET, DELAYED RELEASE / ORAL RLD 2016-09-14 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N205103-002 YOSPRALA 325MG;40MG TABLET, DELAYED RELEASE / ORAL RLD 2016-09-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205103-001 YOSPRALA 81MG;40MG TABLET, DELAYED RELEASE / ORAL RLD 2016-09-14 e64feba35796…2022-09-29 23:25 UTC 2022-09 N205103-002 YOSPRALA 325MG;40MG TABLET, DELAYED RELEASE / ORAL RLD 2016-09-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205103-001 YOSPRALA 81MG;40MG TABLET, DELAYED RELEASE / ORAL RLD 2016-09-14 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205103-002 YOSPRALA 325MG;40MG TABLET, DELAYED RELEASE / ORAL RLD 2016-09-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N205103-001 YOSPRALA 81MG;40MG TABLET, DELAYED RELEASE / ORAL RLD 2016-09-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N205103-002 YOSPRALA 325MG;40MG TABLET, DELAYED RELEASE / ORAL RLD 2016-09-14 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 308 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N205103-001 9987231 2033-01-02 U-2324 2018-07-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205103-001 9539214 2033-03-13 U-1902 2017-01-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205103-002 9987231 2033-01-02 U-2324 2018-07-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205103-002 9539214 2033-03-13 U-1902 2017-01-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N205103-001 9987231 2033-01-02 U-2324 2018-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205103-001 9539214 2033-03-13 U-1902 2017-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205103-002 9987231 2033-01-02 U-2324 2018-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205103-002 9539214 2033-03-13 U-1902 2017-01-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205103-001 9987231 2033-01-02 U-2324 2018-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205103-001 9539214 2033-03-13 U-1902 2017-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205103-002 9987231 2033-01-02 U-2324 2018-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205103-002 9539214 2033-03-13 U-1902 2017-01-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205103-001 9987231 2033-01-02 U-2324 2018-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205103-001 9539214 2033-03-13 U-1902 2017-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205103-002 9987231 2033-01-02 U-2324 2018-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205103-002 9539214 2033-03-13 U-1902 2017-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205103-001 9987231 2033-01-02 U-2324 2018-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205103-001 9539214 2033-03-13 U-1902 2017-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205103-002 9987231 2033-01-02 U-2324 2018-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205103-002 9539214 2033-03-13 U-1902 2017-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205103-001 9987231 2033-01-02 U-2324 2018-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205103-001 9539214 2033-03-13 U-1902 2017-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205103-002 9987231 2033-01-02 U-2324 2018-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205103-002 9539214 2033-03-13 U-1902 2017-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205103-001 9987231 2033-01-02 U-2324 2018-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205103-001 9539214 2033-03-13 U-1902 2017-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205103-002 9987231 2033-01-02 U-2324 2018-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205103-002 9539214 2033-03-13 U-1902 2017-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205103-001 9987231 2033-01-02 U-2324 2018-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205103-001 9539214 2033-03-13 U-1902 2017-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205103-002 9987231 2033-01-02 U-2324 2018-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205103-002 9539214 2033-03-13 U-1902 2017-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205103-001 9987231 2033-01-02 U-2324 2018-07-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205103-001 9539214 2033-03-13 U-1902 2017-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205103-002 9987231 2033-01-02 U-2324 2018-07-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205103-002 9539214 2033-03-13 U-1902 2017-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205103-001 9987231 2033-01-02 U-2324 2018-07-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205103-001 9539214 2033-03-13 U-1902 2017-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205103-002 9987231 2033-01-02 U-2324 2018-07-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205103-002 9539214 2033-03-13 U-1902 2017-01-27 2680178bc6a6…
Observed Orange Book exclusivity history# 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 · 28 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 64950-424 Yosprala aspirin and omeprazole Genus Lifesciences Inc. NDA Current 64950-424 Yosprala aspirin and omeprazole Genus Lifesciences Inc. NDA Current 64950-424 Yosprala aspirin and omeprazole Genus Lifesciences Inc. NDA Current 64950-424 Yosprala aspirin and omeprazole Genus Lifesciences Inc. NDA Current 64950-425 Yosprala aspirin and omeprazole Genus Lifesciences Inc. NDA Current 64950-425 Yosprala aspirin and omeprazole Genus Lifesciences Inc. NDA Current 64950-425 Yosprala aspirin and omeprazole Genus Lifesciences Inc. NDA Current 64950-425 Yosprala aspirin and omeprazole Genus Lifesciences Inc. NDA Current 68071-5102 Yosprala Yosprala NuCare Pharmaceuticals,Inc. NDA Current 68071-5102 Yosprala Yosprala NuCare Pharmaceuticals,Inc. NDA Current 69597-348 ASPIRIN/OMEPRAZOLE aspirin and omeprazole Basiem NDA Current 70347-081 YOSPRALA Aspirin and Omeprazole Aralez Pharmaceuticals Us Inc. NDA Current 70347-325 YOSPRALA Aspirin and Omeprazole Aralez Pharmaceuticals Us Inc. NDA Current 71800-012 Yosprala aspirin and omeprazole Innovida Phamaceutique Corporation NDA Current 71800-012 Yosprala aspirin and omeprazole Innovida Phamaceutique Corporation NDA Current 71800-012 Yosprala aspirin and omeprazole Innovida Phamaceutique Corporation NDA Current 71800-014 aspirin and omeprazole delayed-release tab aspirin and omeprazole Innovida Phamaceutique Corporation NDA Current 71800-014 aspirin and omeprazole delayed-release tab aspirin and omeprazole Innovida Phamaceutique Corporation NDA Current 71800-014 aspirin and omeprazole delayed-release tab aspirin and omeprazole Innovida Phamaceutique Corporation NDA Current 71800-016 Yosprala aspirin and omeprazole Innovida Phamaceutique Corporation NDA Current 71800-016 Yosprala aspirin and omeprazole Innovida Phamaceutique Corporation NDA Current 71800-016 Yosprala aspirin and omeprazole Innovida Phamaceutique Corporation NDA Current 71800-018 aspirin and omeprazole delayed-release tab aspirin and omeprazole Innovida Phamaceutique Corporation NDA Current 71800-018 aspirin and omeprazole delayed-release tab aspirin and omeprazole Innovida Phamaceutique Corporation NDA Current 71800-018 aspirin and omeprazole delayed-release tab aspirin and omeprazole Innovida Phamaceutique Corporation NDA Current 73457-415 aspirin and omeprazole delayed-release tab aspirin and omeprazole Innovida Therapeutique Corporation NDA Current 73568-004 Yosprala aspirin and omeprazole PHARMACEUTIKA LTD NDA Current 73568-005 Yosprala aspirin and omeprazole PHARMACEUTIKA LTD NDA Current