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	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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2016-09-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2016-09-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2016-09-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2016-09-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2016-09-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`3a93d1ddd44b…`

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205103-001	NC	2019-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205103-002	NC	2019-09-14	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N205103-001	NC	2019-09-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205103-002	NC	2019-09-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205103-001	NC	2019-09-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205103-002	NC	2019-09-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205103-001	NC	2019-09-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205103-002	NC	2019-09-14	`ea99ee380514…`

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80416	SUPPL	2024-11-25
80415	SUPPL	2024-11-25
80315	SUPPL	2024-11-22
74825	SUPPL	2023-07-20
74783	SUPPL	2023-07-19
70450	SUPPL	2022-03-09
70443	SUPPL	2022-03-09
70432	SUPPL	2022-03-07
67366	SUPPL	2021-05-03
67365	SUPPL	2021-05-03
67289	SUPPL	2021-04-30
65430	SUPPL	2020-12-01
65370	SUPPL	2020-11-30
65369	SUPPL	2020-11-30
54584	SUPPL	2018-06-14
54526	SUPPL	2018-06-12
54525	SUPPL	2018-06-12
53639	ORIG	2018-04-09
49972	SUPPL	2017-10-06
49951	SUPPL	2017-10-05
45386	ORIG	2016-09-19
45387	ORIG	2016-09-15