Application 200671

Type: NDA
Sponsor: ESPERO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DURLAZA	ASPIRIN	CAPSULE, EXTENDED RELEASE;ORAL	162.5MG	Yes	Yes

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
N200671-001	DURLAZA	ASPIRIN	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2015-09-04

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-09-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200671-001	DURLAZA	162.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-09-04	`f41ea6bd6efb…`

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 3 of 19 · 369 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin	ASPIRIN	Salado Sales, Inc.	cf3139a5-e36e-48e3-bb6c-e102b0cec555	2026-06-25	Warnings	Name fallback generic name: ASPIRIN
Pain Relief Aspirin	ASPIRIN	Rite Aid Corporation	bd69d3d2-5d38-47c6-98a6-124f7a43b8b0	2026-06-25	Warnings	Name fallback generic name: ASPIRIN
Aspirin Regular Strength	ASPIRIN	Walgreen Company	0b27c0fd-7ea8-4588-9169-5ad4e8df77ef	2026-06-25	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	ARMY AND AIR FORCE EXCHANGE SERVICE	e273ead7-7cbc-4fd5-a136-9d3558a35360	2026-06-24	Warnings	Name fallback generic name: ASPIRIN
Pain Relief Aspirin Chewable, Low Dose	ASPIRIN	Rite Aid Corporation	65cdce0f-be04-43ba-8c68-bdce7983cfa1	2026-06-22	Warnings	Name fallback generic name: ASPIRIN
Aspirin Regimen	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	88f425df-712d-4911-824b-94085c7190b6	2026-06-19	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	Meijer Distribution, Inc.	3716a7d4-a555-4e54-aa0a-7b8f3e32addb	2026-06-19	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	L.N.K. International, Inc.	2f6ec676-3832-420e-be91-fce83f6586c8	2026-06-19	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	PD-Rx Pharmaceuticals, Inc.	98c30922-c48c-471a-a72e-50020a11da98	2026-06-17	Warnings	Name fallback generic name: ASPIRIN
LOW DOSE ASPIRIN	ASPIRIN	Famora Inc.	4dc6f119-bbde-db5f-e063-6294a90a9486	2026-06-16	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81	ASPIRIN	Amerisource Bergen	4491faca-f30b-4eb0-bea9-f518f6b2f095	2026-06-15	Warnings	Name fallback generic name: ASPIRIN
LOW DOSE ASPIRIN	ASPIRIN	Pinnacle RX LLC	53c11fb4-ba31-b5e5-e063-6394a90a9c1a	2026-06-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	Rugby Laboratories	63fcd93a-b1db-44ba-8f2b-055a7deb205d	2026-06-04	Warnings	Name fallback generic name: ASPIRIN
Childrens Aspirin	ASPIRIN	Cardinal Health 107, LLC	9200823a-5946-49e8-844e-a39061528e3e	2026-05-22	Warnings	Name fallback generic name: ASPIRIN
Good Sense aspirin	ASPIRIN	L. Perrigo Company	e150dd59-8db8-449f-9c9a-1aa6deb3be2e	2026-05-20	Warnings	Name fallback generic name: ASPIRIN
Aspirin Enteric Coated, Regular Strength	ASPIRIN	Gendose Pharmaceuticals, LLC	10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa	2026-05-15	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Gendose Pharmaceuticals, LLC	119de26f-cce5-401c-81fa-775ebebf6c6f	2026-05-15	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose Chewable Orange	ASPIRIN	Cardinal Health 107, LLC	827bbe77-febb-4352-892f-3fbb2acfc7d5	2026-05-14	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Topco Associates, LLC	56c125de-fabf-41fa-88a4-760d2793f202	2026-05-13	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	Valu Merchandisers Company	1754a9f2-e7e5-4efb-a728-6ba2a7155d11	2026-05-12	Warnings	Name fallback generic name: ASPIRIN

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
58487-001	DURLAZA	Acetylsalicylic Acid	New Haven Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46069	ORIG	2016-09-30
18974	SUPPL	2015-12-10
40038	SUPPL	2015-10-22
32046	SUPPL	2015-10-02
9839	SUPPL	2015-09-17
32045	ORIG	2015-09-15
18973	ORIG	2015-09-14