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 14 of 18 · 350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOW DOSE ASPIRIN	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	c94d750e-5a85-77f5-e053-2995a90a6915	2024-10-15	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 MG	ASPIRIN	Meijer	b3e5711c-9529-4eec-871d-de8efa858b86	2024-10-11	Warnings	Name fallback generic name: ASPIRIN
dg health aspirin	ASPIRIN	Dolgencorp, LLC	0ab34dc7-0110-4fc3-ae53-234e7d7bca3c	2024-10-07	Warnings	Name fallback generic name: ASPIRIN
foster and thrive aspirin	ASPIRIN	Strategic Sourcing Services LLC	4d66a8a8-a1c1-4430-8845-21ae67700c39	2024-10-07	Warnings	Name fallback generic name: ASPIRIN
leader aspirin	ASPIRIN	Cardinal Health 110, LLC. dba Leader	ca603b12-e0f7-4d79-8e0d-4651a788ba9b	2024-10-07	Warnings	Name fallback generic name: ASPIRIN
foster and thrive aspirin	ASPIRIN	McKesson Medical-Surgical, Inc.	e9342478-93d6-45de-948f-f4162ee675b2	2024-10-07	Warnings	Name fallback generic name: ASPIRIN
LOW DOSE ASPIRIN	ASPIRIN	Proficient Rx LP	e839bff7-779a-446d-8486-c0e0a1b6d665	2024-10-01	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose Chewable Orange	ASPIRIN	Proficient Rx LP	9e08b91c-b067-4ccd-ae0d-01f48f992f20	2024-10-01	Warnings	Name fallback generic name: ASPIRIN
meijer LOW DOSE Aspirin	ASPIRIN	Meijer, Inc.	1bf12831-5d50-c1b4-e063-6394a90a6970	2024-09-24	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN	ASPIRIN	TARGET CORPORATION	8ed252be-8fdb-3809-e053-2995a90a4b4f	2024-09-19	Warnings	Name fallback generic name: ASPIRIN
Rugby Aspirin	ASPIRIN	Rugby Laboratories	15922349-2825-45d3-95ff-c5a2879ec225	2024-09-12	Warnings	Name fallback generic name: ASPIRIN
leader aspirin	ASPIRIN	Cardinal Health 110, LLC. dba Leader	b8cc9f78-a292-40eb-819d-bd80a552628f	2024-09-11	Warnings	Name fallback generic name: ASPIRIN
aspirin	ASPIRIN	Publix Super Markets Inc	88b0d897-b93f-42c3-88d0-784dd6c555e4	2024-09-10	Warnings	Name fallback generic name: ASPIRIN
good neighbor pharmacy aspirin	ASPIRIN	Amerisource Bergen	820ceaee-2b49-4204-8ebb-d683d9b62e14	2024-09-10	Warnings	Name fallback generic name: ASPIRIN
equate aspirin chewable	ASPIRIN	Wal-Mart Stores Inc	9147c0ce-fcdb-457c-b9f5-e4edd66e91d0	2024-09-10	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	CVS Pharmacy	5cf74d72-c818-400a-9279-87e209efeb15	2024-09-05	Warnings	Name fallback generic name: ASPIRIN
ASPIRN	ASPIRIN	HF Acquisition Co LLC, DBA HealthFirst	21524b42-f8fd-673c-e063-6294a90a22e8	2024-09-04	Warnings	Name fallback generic name: ASPIRIN
Topcare Aspirin	ASPIRIN	Topco Associates LLC	6615bf85-1f79-4d21-91f9-4248c3cf9b38	2024-09-04	Warnings	Name fallback generic name: ASPIRIN
Good Neighbor Pharmacy Aspirin	ASPIRIN	Amerisource Bergen	d9db6659-6afc-431b-ae05-c941775e6366	2024-09-01	Warnings	Name fallback generic name: ASPIRIN
Topcare Aspirin	ASPIRIN	Topco Associates LLC	8133c3fc-97ce-46b4-8580-7da9f09f622b	2024-08-30	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 · 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