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 11 of 18 · 350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ASPIRIN 325 MG EC	ASPIRIN	Bryant Ranch Prepack	9d0449d2-c0c6-4e74-931b-35dc62584028	2025-03-31	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg	ASPIRIN	Bryant Ranch Prepack	cce1e8bd-63c8-403a-bc32-e6788493f604	2025-03-31	Warnings	Name fallback generic name: ASPIRIN
Signature Select Effervescent Pain Relief	ASPIRIN	Safeway Inc.	304fca65-2867-c963-e063-6394a90a183f	2025-03-14	Warnings	Name fallback generic name: ASPIRIN
LOW DOSE ASPIRIN	ASPIRIN	NCS HealthCare of KY, LLC dba Vangard Labs	ed9a71d6-a56e-416a-bb89-6d41307efc5a	2025-02-27	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	PD-Rx Pharmaceuticals, Inc.	77429b7f-78e4-42c0-8679-ae8da1748848	2025-02-26	Warnings	Name fallback generic name: ASPIRIN
Bufferin Regular Strength Pain Relief	ASPIRIN	Genomma Lab USA	3543b2bf-1062-468a-a5dc-eabb2408af8c	2025-02-25	Warnings	Name fallback generic name: ASPIRIN
Aspirina Caplets	ASPIRIN	Bayer HealthCare LLC.	2e6f5ba8-8e8b-6059-e063-6394a90adcd5	2025-02-18	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg	ASPIRIN	Asclemed USA, Inc.	878dab20-668b-4d7a-a5f8-794a587564d5	2025-02-13	Warnings	Name fallback generic name: ASPIRIN
Enteric Coated Aspirin Regular Strength	ASPIRIN	Time-Cap Labs, Inc	5fbd8bb3-46f9-4089-9a21-b6af97a06106	2025-02-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81mg	ASPIRIN	BETTER LIVING BRANDS LLC.	f300dfbc-7137-79d1-e053-2995a90a636e	2025-02-05	Warnings	Name fallback generic name: ASPIRIN
Low dose aspirin 81mg	ASPIRIN	BETTER LIVING BRANDS LLC.	f300c30b-ab1a-a1b4-e053-2a95a90a1294	2025-02-05	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81	ASPIRIN	WALGREENS	d71a571e-e2ce-7e0a-e053-2a95a90a53e0	2025-01-30	Warnings	Name fallback generic name: ASPIRIN
Regular strength aspirin	ASPIRIN	TARGET CORPORATION	e8c87ccb-8c0c-7830-e053-2995a90a88b7	2025-01-30	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose Chewable Orange	ASPIRIN	NCS HealthCare of KY, LLC dba Vangard Labs	dbdc7cae-b2ed-4504-83a0-0a41b4e45003	2025-01-24	Warnings	Name fallback generic name: ASPIRIN
Ecotrin	ASPIRIN	Medtech Products Inc.	222d187b-aae6-410b-baeb-b2bd42f5c676	2025-01-16	Warnings	Name fallback generic name: ASPIRIN
Chewable Low Dose Aspirin	ASPIRIN	TARGET CORPORATION	f934e72a-2e9f-da17-e053-6394a90a1a2e	2025-01-15	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN 325 MG EC	ASPIRIN	Reliable 1 Laboratories LLC	2ab8564f-f958-7512-e054-00144ff88e88	2025-01-15	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg	ASPIRIN	Reliable 1 Laboratories LLC	b247fe39-7f65-e502-e053-2a95a90a08f1	2025-01-15	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	A-S Medication Solutions	3294ba24-f198-485e-88fc-435964434b80	2025-01-09	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg Low Dose	ASPIRIN	Meijer Distribution Inc	eb29d6be-f095-44b2-b6ed-7e4167b596f8	2025-01-02	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