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 16 of 19 · 369 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Effervescent Pain Reliever	ASPIRIN	CVS PHARMACY	0761147f-1337-606e-e063-6394a90abd5d	2024-08-22	Warnings	Name fallback generic name: ASPIRIN
Dollar General Effervescent Pain Reliever	ASPIRIN	Dolgencorp, Inc	1deab362-a325-3a00-e063-6294a90a9acd	2024-08-01	Warnings	Name fallback generic name: ASPIRIN
Low Dose Aspirin	ASPIRIN	Walmart Inc.	152c013a-c81c-f8f9-e063-6294a90a9f23	2024-07-15	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	Bryant Ranch Prepack	61ecf3c9-42fa-4ae4-bd3b-694090477b9a	2024-07-09	Warnings	Name fallback generic name: ASPIRIN
Best Choice Effervescent Pain Reliever 36	ASPIRIN	VALU MERCHANDISERS COMPANY	12f1278e-88b6-0460-e063-6394a90abf0e	2024-07-03	Warnings	Name fallback generic name: ASPIRIN
Drug Mart Effervescent Pain Relief	ASPIRIN	Discount Drug Mart Inc	1c35f394-a221-6531-e063-6394a90acb8a	2024-07-01	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Wildman Business Group	cdbfcf14-8685-40a9-9778-a3b4329dc1ad	2024-07-01	Warnings	Name fallback generic name: ASPIRIN
Meijer Effervescent Pain Relief	ASPIRIN	Meijer Distribution Inc	17553911-e0fc-e355-e063-6394a90af7b8	2024-06-28	Warnings	Name fallback generic name: ASPIRIN
Aspirin Regular Strength	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	093182a6-3ed8-5a3f-e063-6294a90a354a	2024-06-14	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg Low Dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	18ff2df8-ee65-4219-ad93-cf5090bfac2d	2024-06-13	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg Low dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	bfb9af64-3195-44bf-bcf3-6b36b40d3cc7	2024-06-13	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	609948d6-0f20-4d0c-adc0-6ae72a4f2b7a	2024-06-13	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	3f73a359-59d7-47bb-872e-914b0db719af	2024-06-13	Warnings	Name fallback generic name: ASPIRIN
Low Dose Aspirin	ASPIRIN	Topco Associates	4a6a1dbb-c813-42fd-9bb8-497aec339466	2024-06-11	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN	ASPIRIN	H-E-B	085b35db-62e4-38db-e063-6394a90a9763	2024-06-07	Warnings	Name fallback generic name: ASPIRIN
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	a272bf44-54df-448a-8bff-e31f9488b416	2024-05-06	Warnings	Name fallback generic name: ASPIRIN
St. Joseph Low Dose Aspirin	ASPIRIN	Foundation Consumer Healthcare	dbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f	2024-04-26	Warnings	Name fallback generic name: ASPIRIN
Aspirin 50 CT	ASPIRIN	JHK Inc dba American Safety & First Aid	6009842a-c6ae-4582-a80f-364fc8a13a7a	2024-04-26	Warnings	Name fallback generic name: ASPIRIN
Regular Strength Aspirin 325 mg	ASPIRIN	Kroger	0fc3193d-af4e-ff3a-e063-6294a90a2743	2024-04-17	Warnings	Name fallback generic name: ASPIRIN
aspirin low dose chewable	ASPIRIN	Time-Cap Labs, Inc	5d56618c-8ea2-42ea-a9f2-339bd0055ddd	2024-04-17	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