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 4 of 18 · 350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin 81mg Enteric Coated	ASPIRIN	HHH Pharmaceuticals	d81aec73-c7c1-4c52-80f6-fb0e32caf7aa	2026-05-06	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Better Living Brands, LLC	5ebd04d8-52c7-4c72-a4c1-fc7fd488ea24	2026-05-06	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Geiss, Destin & Dunn Inc.	b8f6e486-5332-4c46-ab6c-7de04c91c60b	2026-05-06	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose Chewable Orange	ASPIRIN	Major Pharmaceuticals	4ba6eed3-004a-4576-b7f7-685fae49cf6a	2026-05-04	Warnings	Name fallback generic name: ASPIRIN
Medique at Home Aspirin	ASPIRIN	Sportpharm LLC	0f2aa75e-534f-478b-811e-fb492b7af9bb	2026-04-24	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Health Pharma USA LLC	503868bb-48e0-b718-e063-6394a90a9c5b	2026-04-24	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg Low Dose	ASPIRIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	23b29044-6389-42ea-839a-5351557a6ce3	2026-04-23	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	United Natural Foods, Inc. dba UNFI	07edcb31-d31d-4607-98c3-dcb1e062cc70	2026-04-22	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	CVS PHARMACY	904a2b21-d911-40c3-9e4b-59543ea5be4f	2026-04-22	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg	ASPIRIN	Preferred Pharmaceuticals Inc.	ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e	2026-04-20	Warnings	Name fallback generic name: ASPIRIN
Aspirin NSAID	ASPIRIN	Valu Merchandisers Company	0cc46a81-54c9-44b7-b384-79d25255eff2	2026-04-17	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	Valu Merchandisers Company	c9e384e5-fa9b-4c75-b5e3-16eb8db662ef	2026-04-16	Warnings	Name fallback generic name: ASPIRIN
Low Dose Aspirin	ASPIRIN	Akron Pharma Inc.	e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed	2026-04-10	Warnings	Name fallback generic name: ASPIRIN
Bayer Genuine Aspirin	ASPIRIN	Navajo Manufacturing Company Inc.	f6f2ce71-5728-aefb-e053-6394a90a20e4	2026-04-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	HyVee Inc	3730ee46-b241-44eb-94fa-52b9d12a9c35	2026-04-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Walgreen Company	82cc404b-fcf5-4e48-ab1a-09d8c47f9e04	2026-04-08	Warnings	Name fallback generic name: ASPIRIN
Pain Relief Aspirin Low Dose	ASPIRIN	Rite Aid Corporation	503408ed-e799-48a0-8d38-3034f4a0ead5	2026-04-02	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg	ASPIRIN	Lidl US LLC	468f4a2f-60f7-4808-95d7-a00be1bb112f	2026-04-02	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	COSTCO WHOLESALE CORPORATION	c8a8986b-1ab4-9da0-71da-42595db08b44	2026-04-02	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	318cc982-23a9-4804-b6fb-248f772d7a38	2026-04-02	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