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 11 of 19 · 369 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adult Low Dose Aspirin	ASPIRIN	Advanced Rx LLC	ad0d6a5c-eee9-406c-8d7f-1df9b45f5340	2025-07-02	Warnings	Name fallback generic name: ASPIRIN
Aspirin Regular Strength	ASPIRIN	United Natural Foods, Inc. dba UNFI	979973c1-661a-4384-8b92-fd901ebde558	2025-07-01	Warnings	Name fallback generic name: ASPIRIN
Regular Strength Enteric coated aspirin	ASPIRIN	ATLANTIC BIOLOGICALS CORP.	e1c8d0ed-da1d-4b1a-9a85-7b8532775f87	2025-06-24	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	ATLANTIC BIOLOGICALS CORP.	024c5054-959f-4ea5-a71f-c0e16cc4b90c	2025-06-24	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose Chewable Orange	ASPIRIN	ATLANTIC BIOLOGICALS CORP.	a0d8ee59-1ce0-4ddd-a90c-54adb512540c	2025-06-24	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	696f55b1-536c-40c4-91f7-b572c39220db	2025-06-11	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Trifecta Pharmaceuticals USA LLC	372be427-acbd-c10c-e063-6294a90a572d	2025-06-09	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81mg Enteric Coated	ASPIRIN	Gendose Pharmaceuticals, LLC	7342bbf4-ebb9-446d-83bb-6ddcb3a44fa7	2025-05-01	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN	ASPIRIN	HF Acquisition Co LLC, DBA HealthFirst	2553d0cb-3f5c-7ea0-e063-6294a90a3cd4	2025-05-01	Warnings, Adverse reactions	Name fallback generic name: ASPIRIN
Aspirin 81mg Enteric Coated	ASPIRIN	Advanced Rx LLC	606067bb-b07f-444e-9465-d1e187735f3a	2025-05-01	Warnings	Name fallback generic name: ASPIRIN
RIGHT REMEDIES LOW DOSE Aspirin 81mg	ASPIRIN	Strive Pharmaceuticals Inc.	322c0e50-cf75-51ab-e063-6294a90a9235	2025-04-14	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81mg	ASPIRIN	Gendose Pharmaceuticals, LLC	1d6552e8-4f89-411f-a352-8f7835851fc0	2025-04-11	Warnings	Name fallback generic name: ASPIRIN
Bayer Aspirin Regimen Chewable Low Dose Aspirin Orange	ASPIRIN	Bayer HealthCare LLC.	0c6ae05f-760f-34d1-e054-00144ff88e88	2025-04-11	Warnings	Name fallback generic name: ASPIRIN
Adult Low Dose Enteric Coated Aspirin	ASPIRIN	NuCare Pharmaceuticals, Inc.	324937c3-c558-bc79-e063-6294a90acc8e	2025-04-08	Warnings	Name fallback generic name: ASPIRIN
Adult Low Dose Enteric Coated Aspirin	ASPIRIN	Geri-Care Pharmaceutical Corp	e327a52a-0e31-44b7-9823-7f60d070ae52	2025-04-01	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN 325 MG EC	ASPIRIN	Bryant Ranch Prepack	9d0449d2-c0c6-4e74-931b-35dc62584028	2025-03-31	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg	ASPIRIN	Bryant Ranch Prepack	cce1e8bd-63c8-403a-bc32-e6788493f604	2025-03-31	Warnings	Name fallback generic name: ASPIRIN
Signature Select Effervescent Pain Relief	ASPIRIN	Safeway Inc.	304fca65-2867-c963-e063-6394a90a183f	2025-03-14	Warnings	Name fallback generic name: ASPIRIN
Adult Low Dose Enteric Coated Aspirin	ASPIRIN	Bi-Mart	08769966-2f6e-4fce-8391-ec1910ab5e7a	2025-03-01	Warnings	Name fallback generic name: ASPIRIN
LOW DOSE ASPIRIN	ASPIRIN	NCS HealthCare of KY, LLC dba Vangard Labs	ed9a71d6-a56e-416a-bb89-6d41307efc5a	2025-02-27	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