Home Applications 074635 Application 074635
Type ANDA
Sponsor CONTRACT PHARMACAL 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 A074635-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13
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 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074635-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 1997-01-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074635-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 1997-01-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 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 13 of 13 · 258 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen Sodium NAPROXEN SODIUM Proficient Rx LP e668c80f-dd53-4b82-8678-5e4fccb13023 2022-05-02 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM betr headache pain relief NAPROXEN SODIUM Live Betr LLC eaf6d2fc-ebcb-4d11-8e3f-a494f0f7920b 2022-04-01 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Walgreens a380cace-43dc-4b9c-84d3-0b38241d9d2e 2022-03-30 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM WALGREEN COMPANY 462a7e41-b899-4e08-8113-b48ece0ad8d8 2022-03-17 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM DISCOUNT DRUG MART, INC. b00c0e86-4c0b-45bf-948f-824ea0f09e39 2022-03-16 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM All Day Pain Relief NAPROXEN SODIUM P & L Development, LLC 7360ae72-3714-402b-96f1-64dc056bafb8 2022-02-08 Warnings Name fallback generic name: NAPROXEN SODIUM NAPROXEN SODIUM NAPROXEN SODIUM TIME CAP LABORATORIES, INC 17ecaee0-c1c6-4360-81c1-d6afe50b9b27 2021-12-01 Warnings Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM NAPROXEN SODIUM NAPROXEN SODIUM Kroger Company bc185bf2-bc2c-f439-e053-2995a90a93d0 2021-06-03 Warnings Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Proficient Rx LP 397db794-027c-4a89-993e-07c208b457a3 2020-09-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Flanax Pain Reliever/Fever reducer NAPROXEN SODIUM Belmora LLC 05337e0b-8baf-42d6-a642-3052f77ed304 2020-05-29 Warnings Name fallback generic name: NAPROXEN SODIUM Ana-Dent PAIN RELIEF NAPROXEN SODIUM Belmora LLC 04721306-2850-4e0a-9dd9-7cabb575f3c7 2020-05-18 Warnings Name fallback generic name: NAPROXEN SODIUM Flanax Pain Reliever/Fever Reducer NAPROXEN SODIUM Belmora LLC a93e4966-9dd3-40ba-b7d6-6ca8fef229c6 2020-05-15 Warnings Name fallback generic name: NAPROXEN SODIUM NAPROXEN SODIUM NAPROXEN SODIUM PuraCap Pharmaceutical LLC fc865e81-164c-48e9-8fb9-6fc27d1c33cf 2019-12-10 Warnings Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM NAPROXEN SODIUM NAPROXEN SODIUM Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd 1d5981dd-e3f5-48a3-a5f1-ce49689cdfac 2019-11-08 Warnings Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM Good Sense Naproxen Sodium NAPROXEN SODIUM Proficient Rx LP c0dc7f87-355c-4357-b99d-f03693d350a7 2019-11-01 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM SA3, LLC 313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9 2019-04-23 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM SUPERVALU INC 1aedc0a1-466a-40c6-bb4c-53b7e8f83aff 2018-12-17 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Premier Value Alliance LLC 803b1569-46f0-4937-842c-0c363fe0ed79 2018-10-30 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM