Home Applications 203697 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 Product TE source text 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 7 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 Pharbest Pharmaceuticals, Inc. 2763a733-d617-4d95-8429-fbf81d9d77fb 2025-12-24 Warnings Name fallback generic name: ASPIRIN Adult Low Dose Aspirin ASPIRIN Pharbest Pharmaceuticals, Inc. 4522f745-b88d-4021-a5dc-0161f1967dc9 2025-12-24 Warnings Name fallback generic name: ASPIRIN Aspirin Pain reliver ASPIRIN Pioneer Life Sciences, LLC 8dc29957-2ac1-47f8-89fd-a6bcf97ee3d3 2025-12-23 Warnings Name fallback generic name: ASPIRIN CAREALL Aspirin ASPIRIN New World Imports, Inc f4aa0de9-ffcc-4140-91a3-fd9e7a55f2ac 2025-12-22 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN L.N.K. International, Inc. 35005045-57b2-4ffe-ab70-22d570c1b161 2025-12-22 Warnings Name fallback generic name: ASPIRIN Aspirin Low Dose ASPIRIN NUVICARE LLC 3a4aa3c7-b726-4303-8803-74196fa5637a 2025-12-19 Warnings Name fallback generic name: ASPIRIN Low Dose Aspirin ASPIRIN CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 8bc75bcf-01c9-41d0-a96f-77a24e3edf01 2025-12-15 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN TOP CARE (Topco Associates LLC) d3df90be-9037-44b2-bf48-540d68a033b2 2025-12-12 Warnings Name fallback generic name: ASPIRIN Low Dose Aspirin ASPIRIN Hy-Vee 98ab6fb7-c7e5-45ab-97c3-81d422f8a843 2025-12-11 Warnings Name fallback generic name: ASPIRIN Low Dose Aspirin ASPIRIN VALU MERCHANDISERS COMPANY 746059b3-ed18-4a81-a70e-4d758e048d8e 2025-12-11 Warnings Name fallback generic name: ASPIRIN Low Dose Chewable Aspirin ASPIRIN VALU MERCHANDISERS COMPANY 7d88f156-d361-4249-b70d-4bbcd5ba30b7 2025-12-11 Warnings Name fallback generic name: ASPIRIN Enteric Coated Aspirin ASPIRIN VALU MERCHANDISERS COMPANY cc18e8e1-652e-44da-a9d7-e56cebda55a1 2025-12-11 Warnings Name fallback generic name: ASPIRIN adult low dose aspirin ASPIRIN VALU MERCHANDISERS COMPANY 6fa1c707-bd42-455b-90a3-2c2a11acc683 2025-12-11 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN VALU MERCHANDISERS COMPANY 049ec1aa-66b3-9273-e063-6294a90a221b 2025-12-11 Warnings Name fallback generic name: ASPIRIN Aspirin 325 ASPIRIN Walgreen Company f7a5d612-443c-4701-ad3b-8eb53c87bece 2025-12-11 Warnings Name fallback generic name: ASPIRIN Low Dose Aspirin ASPIRIN United Natural Foods, Inc. dba UNFI 18b79449-5c4c-41ce-9609-80f5efa0375c 2025-12-09 Warnings Name fallback generic name: ASPIRIN aspirin ASPIRIN Health Pharma USA, LLC 3165b0a3-556b-6abe-e063-6394a90a7682 2025-12-04 Warnings Name fallback generic name: ASPIRIN Bayer Genuine Aspirin ASPIRIN Bayer HealthCare LLC. 44a08904-68b9-4d06-a28d-21aae3d6140c 2025-12-04 Warnings Name fallback generic name: ASPIRIN Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry Flavored ASPIRIN Bayer HealthCare LLC. 070d5713-e018-2913-e054-00144ff8d46c 2025-12-04 Warnings Name fallback generic name: ASPIRIN Bayer Low Dose ASPIRIN Bayer HealthCare LLC. 075b103e-0bb4-4b7a-ac0e-5645bcbd0a07 2025-12-04 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