Home Applications 018965 Application 018965
Type NDA
Sponsor ATNAHS PHARMA US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NAPROSYN NAPROXEN SUSPENSION;ORAL 25MG/ML Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N018965-001 NAPROSYN NAPROXEN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018965-001 AB
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen NAPROXEN Acella Pharmaceuticals, LLC 7e6f03fb-4b36-4418-9684-f45637abbb78 2026-01-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018965 application number: NDA018965 ndc (product): 42192-619
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0121-0899 Naprosyn Naproxen Pharmaceutical Associates, Inc. NDA Current 0121-0899 Naprosyn Naproxen Pharmaceutical Associates, Inc. NDA Current 0121-0899 Naprosyn Naproxen Pharmaceutical Associates, Inc. NDA Current 0121-1798 Naprosyn Naproxen Pharmaceutical Associates, Inc. NDA Current 0121-1798 Naprosyn Naproxen Pharmaceutical Associates, Inc. NDA Current 0121-1798 Naprosyn Naproxen Pharmaceutical Associates, Inc. NDA Current 0121-2697 Naprosyn Naproxen Pharmaceutical Associates, Inc. NDA Current 0121-2697 Naprosyn Naproxen Pharmaceutical Associates, Inc. NDA Current 0121-2697 Naprosyn Naproxen Pharmaceutical Associates, Inc. NDA Current 42192-619 Naproxen Naproxen Acella Pharmaceuticals, LLC NDA Current 70868-200 Naproxen Naproxen Key Therapeutics, LLC NDA Current 71297-200 Naproxen Naproxen Allegis Holdings, LLC NDA Current 71297-200 Naproxen Naproxen Allegis Holdings, LLC NDA Current 71511-701 Naprosyn Naproxen Athena Bioscience NDA Current 71511-701 Naprosyn Naproxen Athena Bioscience, LLC NDA Current 71511-701 Naprosyn Naproxen Athena Bioscience NDA Current