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 12 of 18 · 350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin ASPIRIN Advanced Rx Pharmacy of Tennessee, LLC f8375029-e567-c6a5-e053-6394a90a5b67 2024-12-31 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Advance Pharmaceutical Inc. f6a9ea44-08b8-4a33-bfbd-68cb2d852c39 2024-12-26 Warnings Name fallback generic name: ASPIRIN NobleAid PAIN RELIEVER ASPIRIN Noble Otc LLC aa08e488-2f69-4d7e-86ba-ccfad563edcf 2024-12-18 Warnings Name fallback generic name: ASPIRIN HEB Effervescent Pain Relief ASPIRIN H. E. BUTT GROCERY COMPANY 03876c71-60ec-3280-e063-6294a90a62dc 2024-12-03 Warnings Name fallback generic name: ASPIRIN Market Basket Effervescent Pain Relief ASPIRIN DEMOULAS SUPER MARKETS, INC. 08133bf0-3c8f-e4d0-e063-6294a90af79a 2024-12-03 Warnings Name fallback generic name: ASPIRIN Aspirin Low Dose ASPIRIN WinCo Foods, LLC 4359da13-e851-440b-91b9-6b544bff20d2 2024-12-03 Warnings Name fallback generic name: ASPIRIN Low Dose Aspirin ASPIRIN WinCo Foods, LLC 5b3e8a78-5357-42ad-811e-b2578b25dc7b 2024-12-03 Warnings Name fallback generic name: ASPIRIN Low Strength Chewable Aspirin ASPIRIN Geri-Care Pharmaceutical Corp cc77b9d1-7874-4ce8-a763-3a0e1c2891de 2024-12-03 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Chain Drug Marketing Association 0e3be5f4-bc1b-4b44-a86a-ace89f6ee592 2024-12-02 Warnings Name fallback generic name: ASPIRIN St. Joseph Chewable Low Dose Aspirin ASPIRIN Foundation Consumer Healthcare LLC 248cd302-e380-4837-bdae-9df620b67e8a 2024-12-02 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN AAA Pharmaceutical, Inc. c0c31523-c4c5-43c2-8d72-4d1456c720e9 2024-12-02 Warnings Name fallback generic name: ASPIRIN Aspirin 81mg Adult Low Dose ASPIRIN TopCare 14d010fb-c4a1-4c3d-942f-58719727bfc0 2024-12-02 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Proficient Rx LP 9c186289-e309-45e8-8934-1d0eae0375c2 2024-12-01 Warnings Name fallback generic name: ASPIRIN BAYER Aspirin Original, TRAVEL BASIX ASPIRIN Lil' Drug Store Products, Inc. 7f5d9ebe-8119-49a2-9380-eca18a5e5e85 2024-11-27 Warnings Name fallback generic name: ASPIRIN Chewable Aspirin ASPIRIN MARC GLASSMAN, INC. c8314910-71ff-5a55-e053-2995a90aafc7 2024-11-26 Warnings Name fallback generic name: ASPIRIN Aspirin ASPIRIN Marc Glassman, Inc. 7990ca49-fb30-40fe-9ac4-48e89eac9bb2 2024-11-26 Warnings Name fallback generic name: ASPIRIN Enteric Coated Aspirin Regular Strength ASPIRIN Safeway 96359eb6-62bc-4b13-960c-050af99a8c02 2024-11-26 Warnings Name fallback generic name: ASPIRIN ASPIRIN Low Dose ASPIRIN Marc Glassman, Inc. 3d519af3-9398-4439-8253-1e5d4612b8e3 2024-11-26 Warnings Name fallback generic name: ASPIRIN Family Wellness Pain Reliever ASPIRIN FAMILY WELLNESS SERVICES, INC. 075e19f4-1a58-aedd-e063-6294a90af708 2024-11-20 Warnings Name fallback generic name: ASPIRIN Bayer Genuine Aspirin ASPIRIN Acme United Corporation f7f9dc46-a945-7ae3-e053-6394a90a1192 2024-11-08 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