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 3 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 ARMY AND AIR FORCE EXCHANGE SERVICE e273ead7-7cbc-4fd5-a136-9d3558a35360 2026-06-24 Warnings Name fallback generic name: ASPIRIN Pain Relief Aspirin Chewable, Low Dose ASPIRIN Rite Aid Corporation 65cdce0f-be04-43ba-8c68-bdce7983cfa1 2026-06-22 Warnings Name fallback generic name: ASPIRIN Aspirin Regimen ASPIRIN Cardinal Health 110, LLC. DBA Leader 88f425df-712d-4911-824b-94085c7190b6 2026-06-19 Warnings Name fallback generic name: ASPIRIN Aspirin Low Dose ASPIRIN Meijer Distribution, Inc. 3716a7d4-a555-4e54-aa0a-7b8f3e32addb 2026-06-19 Warnings Name fallback generic name: ASPIRIN Aspirin Low Dose ASPIRIN L.N.K. International, Inc. 2f6ec676-3832-420e-be91-fce83f6586c8 2026-06-19 Warnings Name fallback generic name: ASPIRIN LOW DOSE ASPIRIN ASPIRIN Famora Inc. 4dc6f119-bbde-db5f-e063-6294a90a9486 2026-06-16 Warnings Name fallback generic name: ASPIRIN Aspirin 81 ASPIRIN Amerisource Bergen 4491faca-f30b-4eb0-bea9-f518f6b2f095 2026-06-15 Warnings Name fallback generic name: ASPIRIN LOW DOSE ASPIRIN ASPIRIN Pinnacle RX LLC 53c11fb4-ba31-b5e5-e063-6394a90a9c1a 2026-06-08 Warnings Name fallback generic name: ASPIRIN Aspirin Low Dose ASPIRIN Rugby Laboratories 63fcd93a-b1db-44ba-8f2b-055a7deb205d 2026-06-04 Warnings Name fallback generic name: ASPIRIN Childrens Aspirin ASPIRIN Cardinal Health 107, LLC 9200823a-5946-49e8-844e-a39061528e3e 2026-05-22 Warnings Name fallback generic name: ASPIRIN Good Sense aspirin ASPIRIN L. Perrigo Company e150dd59-8db8-449f-9c9a-1aa6deb3be2e 2026-05-20 Warnings Name fallback generic name: ASPIRIN Aspirin Enteric Coated, Regular Strength ASPIRIN Gendose Pharmaceuticals, LLC 10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa 2026-05-15 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Gendose Pharmaceuticals, LLC 119de26f-cce5-401c-81fa-775ebebf6c6f 2026-05-15 Warnings Name fallback generic name: ASPIRIN Aspirin Low Dose Chewable Orange ASPIRIN Cardinal Health 107, LLC 827bbe77-febb-4352-892f-3fbb2acfc7d5 2026-05-14 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Topco Associates, LLC 56c125de-fabf-41fa-88a4-760d2793f202 2026-05-13 Warnings Name fallback generic name: ASPIRIN Aspirin Low Dose ASPIRIN Valu Merchandisers Company 1754a9f2-e7e5-4efb-a728-6ba2a7155d11 2026-05-12 Warnings Name fallback generic name: ASPIRIN Aspirin Low Dose ASPIRIN DOLGENCORP, LLC a7e27000-a26b-46c2-823e-663f4e76db74 2026-05-11 Warnings Name fallback generic name: ASPIRIN Low Dose Aspirin ASPIRIN Wal-Mart Stores Inc 093e0458-9975-456f-8950-8273c8890b3c 2026-05-11 Warnings Name fallback generic name: ASPIRIN Aspirin Regular Strength ASPIRIN Rugby Laboratories 939fce7e-55df-4dc5-916b-a533448e962f 2026-05-08 Warnings Name fallback generic name: ASPIRIN Extra Strength Aspirin ASPIRIN HHH Pharmaceuticals 90d457bb-79a7-4759-8ee7-6abffbe1e549 2026-05-06 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