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 2 of 18 · 350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin Low Dose Chewable ASPIRIN Better Living Brands, LLC 7afce7b4-c86a-43f7-83cf-15ebffba2f35 2026-07-28 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN DOLGENCORP, LLC 955484a6-2a7a-4b15-a9b4-e888ed5de04c 2026-07-15 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Geri-Care Pharmaceuticals, Corp 58941782-362d-4436-b365-e909bdbd29a2 2026-07-15 Warnings Name fallback generic name: ASPIRIN Aspirin Low Dose ASPIRIN Major Pharmaceuticals 44730dfb-5062-4015-924b-c30b6c2b19c2 2026-07-13 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Amerisource Bergen 2c5e80e8-a979-45fb-9297-8ff294280c25 2026-07-13 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Wal-Mart Stores Inc 8ae16aa2-54bc-4c1a-aa36-93524199a67b 2026-07-09 Warnings Name fallback generic name: ASPIRIN Aspirin Regular Strength ASPIRIN FOODHOLD U.S.A., LLC 9e09b4fb-e015-45ea-8b1c-27faf65572aa 2026-07-09 Warnings Name fallback generic name: ASPIRIN Rapidol Aspirin ASPIRIN Pharmadel LLC 00d9ab0d-ff25-784f-e063-6294a90a8497 2026-07-06 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Trifecta Pharmaceuticals USA LLC 227cefca-acc4-41d0-e063-6394a90a35b9 2026-07-06 Warnings Name fallback generic name: ASPIRIN Bayer Genuine Aspirin ASPIRIN Select Consumer Group 3ca776c2-47ed-5107-e063-6394a90ac5df 2026-07-03 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Rugby Laboratories f7ca9f4a-f8ef-46d2-9536-b69541e6653d 2026-07-02 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN United Natural Foods, Inc. dba UNFI 19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff6 2026-07-02 Warnings Name fallback generic name: ASPIRIN Aspirin 325 mg ASPIRIN Hi-Tech Nutraceuticals, LLC b3426a9a-ea99-da30-e053-2995a90a1e4b 2026-07-01 Warnings Name fallback generic name: ASPIRIN Medline ASPIRIN Medline Industries, LP 4b0c569a-ed7a-e104-e063-6394a90a6d54 2026-06-29 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Strategic Sourcing Services LLC ea2ef485-429e-4c63-ba7b-0a6b32892ad2 2026-06-25 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Chain Drug Marketing Association, Inc. 055d8420-c189-4a9e-acdc-21627935c8eb 2026-06-25 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Topco Associates, LLC 5f32cf74-dbea-496c-ba23-2040ea354f40 2026-06-25 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Salado Sales, Inc. cf3139a5-e36e-48e3-bb6c-e102b0cec555 2026-06-25 Warnings Name fallback generic name: ASPIRIN Pain Relief Aspirin ASPIRIN Rite Aid Corporation bd69d3d2-5d38-47c6-98a6-124f7a43b8b0 2026-06-25 Warnings Name fallback generic name: ASPIRIN Aspirin Regular Strength ASPIRIN Walgreen Company 0b27c0fd-7ea8-4588-9169-5ad4e8df77ef 2026-06-25 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