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 1 of 2 · 21 matching rows.
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 2 of 2 · 122 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 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 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 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 29485-1013 Aleve Naproxen sodium tablet Mechanical Servants LLC NDA Current 29485-1013 Aleve Naproxen sodium tablet Mechanical Servants LLC NDA Current 29485-6751 Aleve Naproxen sodium tablet Mechanical Servants LLC NDA Current 29485-6751 Aleve Naproxen sodium tablet Mechanical Servants LLC NDA Current 29485-7534 Aleve Naproxen sodium tablet Mechanical Servants LLC NDA Current 29485-7534 Aleve Naproxen sodium tablet Mechanical Servants LLC NDA Current 47682-488 Bayer Aleve Naproxen Sodium Unifirst First Aid Corpor NDA Current 47682-488 Bayer Aleve Naproxen Sodium Unifirst First Aid Corporation NDA Current 47682-488 Bayer Aleve Naproxen Sodium Unifirst First Aid Corporation NDA Current 47682-488 Bayer Aleve Naproxen Sodium Unifirst First Aid Corporation NDA Current 47682-488 Bayer Aleve Naproxen Sodium Unifirst First Aid Corporation NDA Current 47682-488 Bayer Aleve Naproxen Sodium Unifirst First Aid Corporation NDA Current 52904-832 Aleve naproxen sodium Select Corporation NDA Current 52904-832 Aleve naproxen sodium Select Corporation NDA Current 53329-675 Naproxen NAPROXEN SODIUM Medline Industries, Inc. NDA Current 66715-5103 Aleve naproxen sodium tablet Lil' Drug Store Products, Inc NDA Current 66715-5103 Aleve naproxen sodium tablet Lil' Drug Store Products, Inc NDA Current 66715-9702 Aleve Naproxen Sodium Lil' Drug Store Products, Inc NDA Current 66715-9702 Aleve Naproxen Sodium Lil' Drug Store Products, Inc NDA Current 66715-9702 Aleve Naproxen Sodium Lil' Drug Store Products, Inc NDA Current 66715-9702 Aleve Naproxen Sodium Lil' Drug Store Products, Inc NDA Current 66715-9702 Aleve Naproxen Sodium Lil' Drug Store Products, Inc NDA Current 67751-144 Aleve NAPROXEN SODIUM Navajo Manufacturing Company Inc. NDA Current 67751-144 Aleve naproxen sodium Navajo Manufacturing Company Inc NDA Current 67751-144 Aleve NAPROXEN SODIUM Navajo Manufacturing Company Inc. NDA Current 67751-144 Aleve naproxen sodium Navajo Manufacturing Company Inc NDA Current 70262-301 Aleve NAPROXEN SODIUM Your Safety Company NDA Current 70264-011 Aleve NAPROXEN SODIUM R J General Corporation NDA Current 70264-011 Aleve NAPROXEN SODIUM R J General Corporation NDA Current 70264-011 Aleve NAPROXEN SODIUM R J General Corporation NDA Current