Home Applications 020067 Application 020067
Type NDA
Sponsor ATNAHS PHARMA US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 EC-NAPROSYN NAPROXEN TABLET, DELAYED RELEASE;ORAL 375MG Yes Yes 003 EC-NAPROSYN NAPROXEN TABLET, DELAYED RELEASE;ORAL 500MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N020067-002 EC-NAPROSYN NAPROXEN 375MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 1994-10-14 N020067-003 EC-NAPROSYN NAPROXEN 500MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 1994-10-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 of 3 · 88 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 2022-10-28 04:53 UTC 2022-10 N020067-002 EC-NAPROSYN 375MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 1994-10-14 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020067-003 EC-NAPROSYN 500MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 1994-10-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020067-002 EC-NAPROSYN 375MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 1994-10-14 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020067-003 EC-NAPROSYN 500MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 1994-10-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020067-002 EC-NAPROSYN 375MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 1994-10-14 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020067-003 EC-NAPROSYN 500MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 1994-10-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020067-002 EC-NAPROSYN 375MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 1994-10-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020067-003 EC-NAPROSYN 500MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 1994-10-14 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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 Zameer Pharmaceuticals LLC d2e5553a-7c90-407c-9f07-3be65560c23a 2025-08-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020067 application number: NDA020067
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 · 19 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0004-6415 EC-Naprosyn naproxen Genentech, Inc. NDA Current 42494-407 EC-NAPROXEN naproxen Cameron Pharmaceuticals, LLC NDA Current 42494-408 EC-NAPROXEN naproxen Cameron Pharmaceuticals, LLC NDA Current 63629-2484 EC-NAPROXEN naproxen Bryant Ranch Prepack NDA Current 63629-2484 EC-NAPROXEN naproxen Bryant Ranch Prepack NDA Current 69437-415 EC-Naprosyn naproxen Canton Laboratories NDA Current 69437-415 EC-Naprosyn naproxen Canton Laboratories NDA Current 69437-415 EC-Naprosyn naproxen Canton Laboratories NDA Current 69437-415 EC-Naprosyn naproxen Canton Laboratories NDA Current 69437-416 EC-Naprosyn naproxen Canton Laboratories NDA Current 69437-416 EC-Naprosyn naproxen Canton Laboratories NDA Current 69437-416 EC-Naprosyn naproxen Canton Laboratories NDA Current 69437-416 EC-Naprosyn naproxen Canton Laboratories NDA Current 69784-500 EC-NAPROXEN naproxen Woodward Pharma Services LLC NDA Current 69784-500 EC-NAPROXEN naproxen Woodward Pharma Services LLC NDA Current 69784-500 EC-NAPROXEN naproxen Woodward Pharma Services LLC NDA Current 69784-501 EC-NAPROXEN naproxen Woodward Pharma Services LLC NDA Current 69784-501 EC-NAPROXEN naproxen Woodward Pharma Services LLC NDA Current 69784-501 EC-NAPROXEN naproxen Woodward Pharma Services LLC NDA Current