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 19 of 19 · 369 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Geritrex Aspirin	ASPIRIN	Geritrex LLC	93fb4359-c93d-46c4-b36e-611b829f514c	2018-10-10	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Aphena Pharma Solutions - Tennessee, LLC	49f46b08-b2fe-4e4d-b235-983dab9740cc	2018-02-18	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Richmond Pharmaceuticals, Inc.	11458142-4953-4f9f-bbb6-4422d085a960	2017-11-01	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Richmond Pharmaceuticals, Inc	236a5672-556a-4d8f-9bb6-5877e363e747	2017-10-30	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Richmond Pharmaceuticals, Inc.	31e76aff-63f6-4ee6-8a48-80a73890e607	2017-10-30	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Richmond Pharmaceuticals, Inc.	6a4c897d-c2a8-41b8-98b7-e7da8e2819ec	2017-10-30	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Advance Pharmaceutical Inc.	f2e7332a-bcd6-4aef-9e4c-a2cef5ea9464	2017-10-30	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Advance Pharmaceutical Inc.	8977b821-2843-4436-bd3b-bb902a4b787e	2017-10-30	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Advance Pharmaceutical Inc.	968afa79-eaae-4cd9-ba0d-3b5eaa466b58	2017-10-30	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