Home Applications 020204 Application 020204
Type NDA
Sponsor BAYER Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 ALEVE NAPROXEN SODIUM TABLET;ORAL 220MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020204-002 ALEVE NAPROXEN SODIUM 220MG TABLET / ORAL RLD, RS 1994-01-11
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 · 43 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 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020204-002 ALEVE EQ 200MG BASE TABLET / ORAL RLD, RS 1994-01-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020204-002 ALEVE EQ 200MG BASE TABLET / ORAL RLD, RS 1994-01-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 f41ea6bd6efb…
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 2 · 21 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aleve NAPROXEN SODIUM TABLET Lil' Drug Store Products, Inc d82586b5-c2ee-3f56-e053-2a95a90a42c4 2022-12-06 Warnings Exact identifier application applno (NDA): 020204 application number: NDA020204
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 2 · 122 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0280-0041 Aleve Headache Pain Naproxen Sodium Bayer HealthCare LLC NDA Current 0280-0041 Aleve Headache Pain Naproxen Sodium Bayer HealthCare LLC NDA Current 0280-0270 Menstridol NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-0270 Menstridol NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-0270 Menstridol NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6000 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6000 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6000 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6000 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6000 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6000 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6000 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6000 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6000 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6000 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6000 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6000 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6010 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6020 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6020 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6020 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6020 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6020 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6020 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6020 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6020 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6020 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6020 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6050 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6060 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6060 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6060 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6060 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6060 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6060 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6060 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6060 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6060 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6070 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6070 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6070 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6070 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6070 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6070 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6070 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6070 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6070 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6070 Aleve NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-6092 Aleve Back and Muscle Pain Naproxen Sodium Bayer HealthCare LLC. NDA Current 0280-6092 Aleve Back and Muscle Pain Naproxen Sodium Bayer HealthCare LLC. NDA Current 0280-6092 Aleve Back and Muscle Pain Naproxen Sodium Bayer HealthCare LLC. NDA Current 0280-6092 Aleve Back and Muscle Pain Naproxen Sodium Bayer HealthCare LLC. NDA Current