Application 203697

Type: NDA
Sponsor: PLX PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VAZALORE	ASPIRIN	CAPSULE;ORAL	325MG	Yes	Yes
002	VAZALORE	ASPIRIN	CAPSULE;ORAL	81MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203697-001	VAZALORE	ASPIRIN	325MG	CAPSULE / ORAL		RLD, RS	2013-01-14
N203697-002	VAZALORE	ASPIRIN	81MG	CAPSULE / ORAL		RLD	2021-02-26

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203697-001	10646431	2032-09-29		Drug product	2023-04-05
N203697-001	10786444	2032-09-29	U-3559		2023-04-05
N203697-001	9216150	2032-09-29		Drug product	2016-04-14
N203697-001	9226892	2032-09-29	U-1731		2016-04-14
N203697-001	9226892	2032-09-29	U-1732		2016-04-14
N203697-001	9226892	2032-09-29	U-1733		2016-04-14
N203697-002	10646431	2032-09-29		Drug product	2023-04-05
N203697-002	10786444	2032-09-29	U-3559		2023-04-27

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 · 78 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	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203697-002	VAZALORE	81MG	CAPSULE / ORAL	RLD	2021-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203697-001	VAZALORE	325MG	CAPSULE / ORAL	RLD, RS	2013-01-14	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 349 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203697-001	10646431	2032-09-29		Drug product	2023-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203697-001	10786444	2032-09-29	U-3559		2023-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203697-001	9216150	2032-09-29		Drug product	2016-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203697-001	9226892	2032-09-29	U-1733		2016-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203697-001	9226892	2032-09-29	U-1731		2016-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203697-001	9226892	2032-09-29	U-1732		2016-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203697-002	10646431	2032-09-29		Drug product	2023-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203697-002	10786444	2032-09-29	U-3559		2023-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203697-001	10646431	2032-09-29		Drug product	2023-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203697-001	10786444	2032-09-29	U-3559		2023-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203697-001	9216150	2032-09-29		Drug product	2016-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203697-001	9226892	2032-09-29	U-1733		2016-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203697-001	9226892	2032-09-29	U-1731		2016-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203697-001	9226892	2032-09-29	U-1732		2016-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203697-002	10646431	2032-09-29		Drug product	2023-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203697-002	10786444	2032-09-29	U-3559		2023-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203697-001	10646431	2032-09-29		Drug product	2023-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203697-001	10786444	2032-09-29	U-3559		2023-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203697-001	9216150	2032-09-29		Drug product	2016-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203697-001	9226892	2032-09-29	U-1733		2016-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203697-001	9226892	2032-09-29	U-1731		2016-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203697-001	9226892	2032-09-29	U-1732		2016-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203697-002	10646431	2032-09-29		Drug product	2023-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203697-002	10786444	2032-09-29	U-3559		2023-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203697-001	10646431	2032-09-29		Drug product	2023-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203697-001	10786444	2032-09-29	U-3559		2023-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203697-001	9216150	2032-09-29		Drug product	2016-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203697-001	9226892	2032-09-29	U-1733		2016-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203697-001	9226892	2032-09-29	U-1731		2016-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203697-001	9226892	2032-09-29	U-1732		2016-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203697-002	10646431	2032-09-29		Drug product	2023-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203697-002	10786444	2032-09-29	U-3559		2023-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203697-001	10646431	2032-09-29		Drug product	2023-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203697-001	10786444	2032-09-29	U-3559		2023-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203697-001	9216150	2032-09-29		Drug product	2016-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203697-001	9226892	2032-09-29	U-1733		2016-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203697-001	9226892	2032-09-29	U-1731		2016-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203697-001	9226892	2032-09-29	U-1732		2016-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203697-002	10646431	2032-09-29		Drug product	2023-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203697-002	10786444	2032-09-29	U-3559		2023-04-27	`6a471c1ec25d…`

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 6 of 18 · 350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ASPIRIN Low Strength	ASPIRIN	CVS Pharmacy	6e1c1129-562b-4a8a-ac37-db3cb2a82735	2026-02-11	Warnings	Name fallback generic name: ASPIRIN
good sense aspirin	ASPIRIN	L. Perrigo Company	e9fddbc1-11fe-4cf6-8794-1650fa1b32ae	2026-02-07	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Chain Drug Marketing Association, Inc.	2d375ec9-a528-4048-a15b-652fa20e74a7	2026-02-06	Warnings	Name fallback generic name: ASPIRIN
Adult Low Dose Enteric Coated Aspirin	ASPIRIN	Sportpharm LLC	d3379569-7949-4f78-b634-5d4178b21ea4	2026-02-06	Warnings	Name fallback generic name: ASPIRIN
Buffered Aspirin	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	e5f68c1a-21f3-45a1-861f-229a95b3721c	2026-02-06	Warnings	Name fallback generic name: ASPIRIN
basic care aspirin	ASPIRIN	Amazon.com Services LLC	265c7d85-a666-4234-9c30-ca8e31f4bcb8	2026-02-03	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN	ASPIRIN	Strategic Sourcing Services LLC	8acdbcf9-64a0-4dda-b60e-7e122254ecf3	2026-01-29	Warnings	Name fallback generic name: ASPIRIN
Adult Low Dose Aspirin	ASPIRIN	NCS HealthCare of KY, LLC dba Vangard Labs	9105eff0-1c22-4298-8ee5-9fb7a1de12f1	2026-01-23	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	HyVee Inc	957b13a4-4086-459f-8fa0-9708b317fabe	2026-01-15	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN	ASPIRIN	HART Health	a1c73edf-861d-478b-9d3c-0eddcc6879cc	2026-01-14	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg	ASPIRIN	HYVEE INC	3e602287-565e-a5b9-e063-6294a90abc17	2026-01-13	Warnings	Name fallback generic name: ASPIRIN
Chewable Aspirin 81 mg	ASPIRIN	HYVEE INC	459f749f-9d23-8752-e063-6394a90a8c81	2026-01-13	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN 325 mg	ASPIRIN	HYVEE INC	459d01df-6ff6-cff6-e063-6394a90ab35c	2026-01-13	Warnings	Name fallback generic name: ASPIRIN
Aspirin Packs	ASPIRIN	Sina Health Inc	2865a2c3-53fc-ab9a-e063-6394a90a1418	2026-01-12	Warnings	Name fallback generic name: ASPIRIN
Aspirin enteric coated low dose	ASPIRIN	Walgreen Company	186a6270-e3de-4499-88a4-5f723fee3e34	2026-01-12	Warnings	Name fallback generic name: ASPIRIN
Low Dose Aspirin	ASPIRIN	Family Dollar Services Inc	d35d798e-76f1-454d-86f6-ad11c3bf17d8	2026-01-12	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	INVAHEALTH INC	e5e8a8d5-9174-7975-e053-2a95a90a9aa6	2026-01-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Amerisource Bergen	c3099892-a8cd-4574-a6f9-041e59e2feae	2026-01-07	Warnings	Name fallback generic name: ASPIRIN
Aspirin Pain reliver	ASPIRIN	Pioneer Life Sciences, LLC	c2759844-a49c-450f-e053-2a95a90a2972	2025-12-26	Warnings	Name fallback generic name: ASPIRIN
Aspirin 325 mg	ASPIRIN	BETTER LIVING BRANDS, LLC	424a242f-c8c6-9dd7-e063-6394a90ab4d5	2025-12-24	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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
73089-081	VAZALORE	Aspirin	PLx Pharma Inc	NDA	Current
73089-081	VAZALORE	Aspirin	PLx Pharma Inc	NDA	Current
73089-081	VAZALORE	Aspirin	PLx Pharma Inc	NDA	Current
73089-081	VAZALORE	Aspirin	PLx Pharma Inc	NDA	Current
73089-081	VAZALORE	Aspirin	PLx Pharma Inc	NDA	Current
73089-325	VAZALORE	aspirin	PLx Pharma Inc	NDA	Current
73089-325	VAZALORE	aspirin	PLx Pharma Inc	NDA	Current
73089-325	VAZALORE	aspirin	PLx Pharma Inc	NDA	Current
73089-325	VAZALORE	aspirin	PLx Pharma Inc	NDA	Current
73089-325	VAZALORE	aspirin	PLx Pharma Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72254	SUPPL	2022-10-05
72236	SUPPL	2022-10-04
69399	SUPPL	2021-11-23
69334	SUPPL	2021-11-17
61253	SUPPL	2019-12-12
61252	SUPPL	2019-12-12
55105	SUPPL	2018-08-03
55011	SUPPL	2018-07-26
50494	SUPPL	2017-11-27
40322	ORIG	2014-01-14
44888	ORIG	2013-11-05
22933	ORIG	2013-11-05
10245	ORIG	2013-01-16