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 1 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 Strategic Sourcing Services LLC 7ce4807e-7bd5-41f1-a9c7-1f3af6acdc09 2026-09-09 Warnings Name fallback generic name: ASPIRIN Aspirin Regular Strength ASPIRIN Cardinal Health 110, LLC. DBA Leader 2777beea-06d7-4ff5-ae4a-ad7a117dfb62 2026-09-02 Warnings Name fallback generic name: ASPIRIN Adult Low Dose Chewable Aspirin ASPIRIN Farmacias De Similares TX LLC 513ea306-74c6-96e3-e063-6394a90a8262 2026-09-01 Warnings Name fallback generic name: ASPIRIN Aspirin 81 mg ASPIRIN HAWAII REPACK, INC. ac94cce3-9a39-41de-bb8b-10a5e5b8e83b 2026-08-28 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN WinCo Foods, LLC a0a19cd1-eb8a-4773-be00-78de90d2a3c3 2026-08-28 Warnings Name fallback generic name: ASPIRIN equate aspirin ASPIRIN Wal-Mart Stores Inc ea3f8eed-7b70-4156-9586-125d27bf29a8 2026-08-19 Warnings Name fallback generic name: ASPIRIN aspirin chewable, low dose ASPIRIN United Natural Foods, Inc. dba UNFI 6a6ac7fe-91a4-4b55-979a-b53b51505d8b 2026-08-19 Warnings Name fallback generic name: ASPIRIN Aspirin 81mg ASPIRIN HARRIS TEETER 54e69d5a-55d7-4ebe-8494-0be93613f1e2 2026-08-12 Warnings Name fallback generic name: ASPIRIN Chewable Aspirin ASPIRIN HARRIS TEETER c6a28c83-60c9-3304-e053-2a95a90aa06c 2026-08-12 Warnings Name fallback generic name: ASPIRIN ASPIRIN ASPIRIN HARRIS TEETER 93cbd3cb-1072-89e6-e053-2995a90a2f15 2026-08-12 Warnings Name fallback generic name: ASPIRIN Adult Chewable Aspirin ASPIRIN HARRIS TEETER c6a28617-1769-7a7d-e053-2995a90a1ea0 2026-08-12 Warnings Name fallback generic name: ASPIRIN ASPIRIN ASPIRIN Amazon.com Services LLC c7cc0681-4c0b-4565-99df-d0168c8ba1ba 2026-08-10 Warnings Name fallback generic name: ASPIRIN Gencare-Aspirin Low Dose Pain reliever (NSAID) ASPIRIN Pioneer Life Sciences, LLC 24d4f46a-c7a5-4e94-804f-1e307d8e8cfc 2026-08-09 Warnings Name fallback generic name: ASPIRIN Aspirin 81 mg ASPIRIN DOLGENCORP, LLC b4064039-2345-4227-b83d-54dc13a838d3 2026-08-07 Warnings Name fallback generic name: ASPIRIN Aspirin Low Dose ASPIRIN United Natural Foods, Inc. dba UNFI 87def9e0-0246-42cf-b8ea-2513d52e9f68 2026-08-07 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN P & L Development, LLC 4cd74cec-a209-4e92-b853-fbe5c95f7678 2026-08-06 Warnings Name fallback generic name: ASPIRIN pain relief aspirin Low Dose ASPIRIN Rite Aid Corporation df7835c9-f10f-40c6-8955-61423d94b677 2026-08-05 Warnings Name fallback generic name: ASPIRIN Aspirin Low Dose ASPIRIN DOLGENCORP, LLC 7396c97e-8a51-4a21-8208-f13258b5285c 2026-08-05 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 3ba0a9f2-062a-401e-82eb-54383a822366 2026-07-29 Warnings Name fallback generic name: ASPIRIN Aspirin 81mg Enteric Coated ASPIRIN Cardinal Health 107, LLC 277723db-3578-4842-92eb-2de325f87649 2026-07-28 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