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 9 of 18 · 350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin Low Dose	ASPIRIN	Preferred Pharmaceuticals Inc.	29214eec-860c-43f0-83c6-9ed5a9f530af	2025-09-22	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN	ASPIRIN	Kroger Company	bbee8ee4-e09d-3ba6-e053-2a95a90af647	2025-09-19	Warnings	Name fallback generic name: ASPIRIN
Aspirin Enteric Coated, Regular Strength	ASPIRIN	Walgreen Company	5e1484d3-5be1-40da-a3bf-fb19f7d27d45	2025-09-18	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg Low Dose	ASPIRIN	HEB	926fe7b6-9607-469f-912f-4019891067a9	2025-09-10	Warnings	Name fallback generic name: ASPIRIN
Bayer Genuine Aspirin	ASPIRIN	Unifirst First Aid Corporation	356e4ff4-a7f1-4a50-9b86-2555e232b300	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
Medique at Home Aspirin	ASPIRIN	Unifirst First Aid Corporation	b5a469c1-9ab4-5bd7-e053-2995a90a86d1	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
Medique Products Aspirin	ASPIRIN	Unifirst First Aid Corporation	9b28fed0-a993-ca72-e053-2995a90ac7fd	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
Unishield Aspirin	ASPIRIN	Unishield	ba106b20-32ac-df90-e053-2995a90adaef	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
Travel Savvy Aspirin	ASPIRIN	Bellegrove Medical Supply, Inc.	bae80044-ad7f-3bf5-e053-2995a90a42f9	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
McKesson Aspirin	ASPIRIN	McKesson Medical-Surgical	dabd741e-e11c-52c1-e053-2a95a90a91d5	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
Direct Safety Aspirin	ASPIRIN	Direct Safety	ba9ba697-d3df-49d7-e053-2a95a90af406	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
ULINE Aspirin	ASPIRIN	ULINE	9b2b053c-11e7-8169-e053-2995a90ae336	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
Green Guard Chewable Aspirin 81 mg	ASPIRIN	Unifirst First Aid Corporaiton	173a53ca-b6ea-2042-e063-6294a90a8437	2025-09-08	Warnings	Name fallback generic name: ASPIRIN
Medique Products Chewable Low Dose Aspirin	ASPIRIN	Unifirst First Aid Corporation	17009501-674d-c839-e063-6294a90a59fa	2025-09-08	Warnings	Name fallback generic name: ASPIRIN
Thompson Aspirin	ASPIRIN	Thompson	9623d9c6-f241-bf4a-e053-2a95a90a4eb5	2025-09-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin Enteric Coated Low Dose	ASPIRIN	Walgreen Company	b11a4c4e-374c-403e-a757-5e9700f9f03b	2025-08-27	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose Safety Coated	ASPIRIN	BJWC (Berkley & Jensen / BJ's)	577035a5-88ab-431c-8598-7a19dd633fe9	2025-08-26	Warnings	Name fallback generic name: ASPIRIN
Low Dose Aspirin	ASPIRIN	BJWC (Berkley & Jensen / BJ's)	2f32b096-d29a-c7c7-e063-6294a90a2bbe	2025-08-22	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	PROSTAT FIRST AID	3bdb9d89-9000-69f9-e063-6294a90a0c97	2025-08-08	Warnings	Name fallback generic name: ASPIRIN
Aspi-Cor	ASPIRIN	L.N.K. International, Inc.	9f919a48-ffd8-49fa-b6fd-ec71cc12e64b	2025-08-08	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