Home Applications 205497 Application 205497
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NAPROXEN SODIUM NAPROXEN SODIUM TABLET;ORAL 220MG No 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 A205497-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18
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 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205497-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2016-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205497-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2016-03-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 cb3db0bc1861…
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 · 12 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 27854-700 Flanax Pain Reliever/Fever Reducer Naproxen sodium Belmora LLC ANDA Current 27854-701 Ana-Dent PAIN RELIEF Naproxen Sodium Belmora LLC ANDA Current 58602-735 Naproxen Sodium HEADACHE PAIN Naproxen Sodium Aurohealth LLC ANDA Current 58602-735 Naproxen Sodium HEADACHE PAIN Naproxen Sodium Aurohealth LLC ANDA Current 58602-736 Naproxen Sodium BACK AND MUSCLE PAIN Naproxen Sodium Aurohealth LLC ANDA Current 58602-736 Naproxen Sodium BACK AND MUSCLE PAIN Naproxen Sodium Aurohealth LLC ANDA Current 58602-737 Naproxen Sodium HEADACHE PAIN Naproxen Sodium Aurohealth LLC ANDA Current 58602-737 Naproxen Sodium HEADACHE PAIN Naproxen Sodium Aurohealth LLC ANDA Current 58602-738 Naproxen Sodium Naproxen Sodium Aurohealth LLC ANDA Current 58602-738 Naproxen Sodium Naproxen Sodium Aurohealth LLC ANDA Current 58602-738 Naproxen Sodium Naproxen Sodium Aurohealth LLC ANDA Current 58602-738 Naproxen Sodium Naproxen Sodium Aurohealth LLC ANDA Current 58602-739 Naproxen Sodium BACK AND MUSCLE PAIN Naproxen Sodium Aurohealth LLC ANDA Current 58602-739 Naproxen Sodium BACK AND MUSCLE PAIN Naproxen Sodium Aurohealth LLC ANDA Current 58602-819 Naproxen Sodium Naproxen Sodium Aurohealth LLC ANDA Current 58602-819 Naproxen Sodium Naproxen Sodium Aurohealth LLC ANDA Current 58602-819 Naproxen Sodium Naproxen Sodium Aurohealth LLC ANDA Current 58602-819 Naproxen Sodium Naproxen Sodium Aurohealth LLC ANDA Current 58602-845 Naproxen Sodium Naproxen Sodium Aurohealth LLC ANDA Current 58602-845 Naproxen Sodium Naproxen Sodium Aurohealth LLC ANDA Current