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 18 of 19 · 369 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin	ASPIRIN	A-S Medication Solutions	12feb32b-4b8c-4b17-9e86-cb286457b088	2023-11-01	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN	ASPIRIN	AMERIFOODS TRADING COMPANY	f6cec280-17a5-5c5d-e053-6394a90a81aa	2023-10-31	Warnings	Name fallback generic name: ASPIRIN
Regular Strength Aspirin	ASPIRIN	CARDINAL HEALTH, INC.	8aaa82c6-b46b-25c5-e053-2a95a90a3793	2023-10-30	Warnings	Name fallback generic name: ASPIRIN
ENTERIC COATED ASPIRIN	ASPIRIN	Magno-Humphries, Inc.	a7c02378-4213-4e57-aca2-2437ad02f786	2023-10-27	Warnings	Name fallback generic name: ASPIRIN
Regular Strength Enteric coated aspirin	ASPIRIN	Geri-Care Pharmaceutical Corp	c321208c-f192-42c5-9454-e0df5d02d685	2023-10-26	Warnings	Name fallback generic name: ASPIRIN
Tri-Buffered Aspirin	ASPIRIN	Proficient Rx LP	640c3311-2abf-40b2-82b9-9fe4d8c1cf1d	2023-10-01	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	Better Living Brands LLC	4a76e898-3204-4f77-bc67-c19f5fe829f3	2023-07-05	Warnings	Name fallback generic name: ASPIRIN
Aspirin 325 mg	ASPIRIN	WALGREENS	d71a22e8-9e39-a672-e053-2a95a90a1403	2022-07-08	Warnings	Name fallback generic name: ASPIRIN
aspirin	ASPIRIN	Padagis US LLC	cce244aa-cd79-49c8-b68e-267f2bd0ef67	2022-04-30	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81mg Enteric coated Low Strength Aspirin Regimen	ASPIRIN	Allegiant Health	847fd2f8-2e32-4ef2-a793-b902045110f1	2021-11-19	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81mg Enteric coated Delayed Release	ASPIRIN	Allegiant Health	d6c7c8c9-b997-4acc-a066-133bfb1239cb	2021-11-02	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81mg Enteric coated Delayed Release	ASPIRIN	Dr. Wayne's	eacbdf9e-5642-4986-a03c-b0812d28265d	2021-11-02	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81mg Enteric coated Low Strength Aspirin Regimen	ASPIRIN	Allegiant Health	d9abe780-7e58-43d8-848f-c6c8893aea2e	2021-10-14	Warnings	Name fallback generic name: ASPIRIN
Low Dose Miniprin Enteric Safety Coated	ASPIRIN	Time-Cap Labs, Inc	5a38a643-55b0-4a6c-84e1-ee2374435114	2018-12-19	Warnings	Name fallback generic name: ASPIRIN
Low Dose Aspirin Enteric Safety Coated	ASPIRIN	Time-Cap Labs, Inc	55d645bb-8645-4984-a7b9-3e6eed8c6412	2018-12-17	Warnings	Name fallback generic name: ASPIRIN
Low Dose Aspirin Enteric Safety Coated	ASPIRIN	Time-Cap Labs, Inc	9cb0c2df-5e72-42c5-ae93-144201fd263c	2018-12-17	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN EXTRA STRENGTH	ASPIRIN	Time-Cap Labs, Inc	efc7d42a-241a-422d-bc08-be2f5f774b62	2018-12-17	Warnings	Name fallback generic name: ASPIRIN
aspirin low dose enteric coated	ASPIRIN	Time-Cap Labs, Inc	5aaf8b66-b00e-4bc8-972c-bbe6825284fb	2018-12-17	Warnings	Name fallback generic name: ASPIRIN
aspirin low dose enteric coated	ASPIRIN	Time-Cap Labs, Inc	7146c505-2469-4bc2-9e1e-ceb60951c8ae	2018-12-17	Warnings	Name fallback generic name: ASPIRIN
Aspirin Delayed Release	ASPIRIN	Time-Cap Labs, Inc	70d8ba6c-8dfe-402a-817d-22544141d160	2018-12-14	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