Home Applications 207612 Application 207612
Type ANDA
Sponsor NOVELGENIX THERAPS 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 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 A207612-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16
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 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207612-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2018-11-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207612-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2018-11-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207612-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2018-11-16 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 4 of 13 · 252 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Leader All Day Pain Relief NAPROXEN SODIUM Cardinal Health 110, LLC. dba Leader dbf007f5-c792-43a7-8cc1-bfa617f3a7fa 2026-01-26 Warnings Name fallback generic name: NAPROXEN SODIUM naproxen sodium NAPROXEN SODIUM Meijer Distribution Inc f4e57560-ae89-4fc3-a66b-ebf3dc3f2448 2026-01-22 Warnings Name fallback brand name: naproxen sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM HYVEE INC 45a0c910-7dd7-6a42-e063-6394a90a491c 2026-01-13 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM HYVEE INC 45a00020-173b-a4a1-e063-6294a90ae399 2026-01-13 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naprelan NAPROXEN SODIUM Upsher-Smith Laboratories, LLC b8a51c9a-488e-4377-a041-436f6a2f8893 2026-01-08 Boxed warning, Warnings, Adverse reactions Name fallback generic name: NAPROXEN SODIUM Flanax NAPROXEN SODIUM Belmora LLC 2c099d45-f03a-4161-a6af-8fe5965f2748 2026-01-06 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM PD-Rx Pharmaceuticals, Inc. 145cdcc0-9bd5-4a0e-81fc-11a24d181980 2026-01-05 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Safeway, Inc. deb1be0f-64ae-46b5-b54a-1a58eec6492e 2026-01-05 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Glenmark Pharmaceuticals Inc., USA 6c5bb008-e66f-4ef0-bf84-aca7eb5983e9 2025-12-23 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Granules USA, Inc. 8cb8030c-b281-315c-e053-2a95a90a36f0 2025-12-22 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Safeway, Inc f2a297c2-3898-5e47-e053-2995a90ab3cc 2025-12-19 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM TARGET CORPORATION fdb87abd-3176-dd62-e053-6394a90a6fcc 2025-12-19 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM CVS 1042b202-e8ee-1839-e063-6294a90ac90b 2025-12-19 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM CVS 10429d07-de96-5542-e063-6294a90a7371 2025-12-19 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM signature care naproxen sodium NAPROXEN SODIUM Safeway 85f78e63-98aa-4cf3-887d-0ac535184f97 2025-12-16 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM MEIJER DISTRIBUTION INC 89f82399-9f71-49dd-8710-b60f346c576c 2025-12-12 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM VALU MERCHANDISERS COMPANY 12748345-0d79-d6f8-e063-6394a90ab6c6 2025-12-11 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM VALU MERCHANDISERS COMPANY 1274889d-803c-d7fd-e063-6394a90ab9a8 2025-12-11 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM All Day Pain Relief NAPROXEN SODIUM WALMART INC. c4909e43-57ba-44bc-a234-a02cc884891c 2025-12-11 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Chain Drug Marketing Association d9e72c3f-addc-4391-a7a4-2680a3e7f5c4 2025-12-10 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 46994-661 NAPROXEN SODIUM NAPROXEN SODIUM SAVE-A-LOT FOOD STORES, LTD. ANDA Current 46994-661 NAPROXEN SODIUM NAPROXEN SODIUM SAVE-A-LOT FOOD STORES, LTD. ANDA Current 46994-661 NAPROXEN SODIUM NAPROXEN SODIUM SAVE-A-LOT FOOD STORES, LTD. ANDA Current 50090-4704 Naproxen sodium Naproxen sodium A-S Medication Solutions ANDA Current 50090-4704 Naproxen sodium Naproxen sodium A-S Medication Solutions ANDA Current 68210-4120 Naproxen Sodium Naproxen Sodium Spirit Pharmaceuticals LLC ANDA Current 68210-4121 Naproxen Sodium Naproxen Sodium Spirit Pharmaceuticals LLC ANDA Current 68210-4137 Naproxen Sodium Naproxen Sodium Spirit Pharmaceuticals LLC ANDA Current 68210-4137 Naproxen Sodium Naproxen Sodium Spirit Pharmaceuticals LLC ANDA Current 68210-4137 Naproxen Sodium Naproxen Sodium Spirit Pharmaceuticals LLC ANDA Current 68210-4137 Naproxen Sodium Naproxen Sodium Spirit Pharmaceuticals LLC ANDA Current 68210-4137 Naproxen Sodium Naproxen Sodium Spirit Pharmaceuticals LLC ANDA Current 69230-313 Naproxen sodium Naproxen sodium Camber Consumer Care ANDA Current 72090-003 Pain and Fever Relief Naproxen Sodium Pioneer Life Sciences, LLC ANDA Current