Home Applications 074661 Application 074661
Type ANDA
Sponsor PERRIGO 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 A074661-001 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 · 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 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074661-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 1997-01-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074661-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 1997-01-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 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 3 of 3 · 56 matching rows.
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 5 · 328 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0901 Good Sense Naproxen Sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-0901 Good Sense Naproxen Sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-0901 Good Sense Naproxen Sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-0901 Good Sense Naproxen Sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-1412 good sense naproxen sodium naproxen sodium L. Perrigo Company ANDA Current 0113-1773 good sense naproxen sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-4368 Good Sense Naproxen Sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-4368 Good Sense Naproxen Sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-4368 Good Sense Naproxen Sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-4368 Good Sense Naproxen Sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-7033 basic care naproxen sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-7033 basic care naproxen sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-7368 Basic Care Naproxen Sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-7368 Basic Care Naproxen Sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-7901 basic care naproxen sodium Naproxen Sodium L. Perrigo Company ANDA Current 0113-7901 basic care naproxen sodium Naproxen Sodium L. Perrigo Company ANDA Current 0363-0140 pain relief Naproxen sodium Walgreen Company ANDA Current 0363-0140 pain relief Naproxen sodium Walgreen Company ANDA Current 0363-0140 pain relief Naproxen sodium Walgreen Company ANDA Current 0363-0140 pain relief Naproxen sodium Walgreen Company ANDA Current 0363-0368 All Day Pain Relief Naproxen Sodium Walgreen Company ANDA Current 0363-0368 All Day Pain Relief Naproxen Sodium Walgreen Company ANDA Current 0363-0368 All Day Pain Relief Naproxen Sodium Walgreen Company ANDA Current 0363-0368 All Day Pain Relief Naproxen Sodium Walgreen Company ANDA Current 0363-0490 Pain Relief Naproxen Sodium Walgreen Company ANDA Current 0363-0490 Pain Relief Naproxen Sodium Walgreen Company ANDA Current 0363-0938 all day pain relief Naproxen Sodium Walgreen Company ANDA Current 0363-0938 all day pain relief Naproxen Sodium Walgreen Company ANDA Current 0363-0938 all day pain relief Naproxen Sodium Walgreen Company ANDA Current 0536-1093 Rugby All Day Relief Naproxen Sodium Rugby Laboratories ANDA Current 0536-1093 Rugby All Day Relief Naproxen Sodium Rugby Laboratories ANDA Current 0536-1093 Rugby All Day Relief Naproxen Sodium Rugby Laboratories ANDA Current 0536-1093 Rugby All Day Relief Naproxen Sodium Rugby Laboratories ANDA Current 0536-1094 rugby all day relief Naproxen Sodium Rugby Laboratories ANDA Current 0536-1094 rugby all day relief Naproxen Sodium Rugby Laboratories ANDA Current 0536-1094 rugby all day relief Naproxen Sodium Rugby Laboratories ANDA Current 0536-1094 rugby all day relief Naproxen Sodium Rugby Laboratories ANDA Current 10202-490 7 Select Naproxen Sodium Naproxen Sodium 7-Eleven ANDA Current 10202-490 7 Select Naproxen Sodium Naproxen Sodium 7-Eleven ANDA Current 11673-368 up and up naproxen sodium Naproxen Sodium Target Corporation ANDA Current 11673-368 up and up naproxen sodium Naproxen Sodium Target Corporation ANDA Current 11673-368 up and up naproxen sodium Naproxen Sodium Target Corporation ANDA Current 11673-368 up and up naproxen sodium Naproxen Sodium Target Corporation ANDA Current 11673-909 up and up naproxen sodium naproxen sodium Target Corporation ANDA Current 11673-909 up and up naproxen sodium naproxen sodium Target Corporation ANDA Current 11673-909 up and up naproxen sodium naproxen sodium Target Corporation ANDA Current 11822-0140 Naproxen Sodium Naproxen sodium Rite Aid Corporation ANDA Current 11822-0140 Naproxen Sodium Naproxen sodium Rite Aid Corporation ANDA Current 11822-0140 Naproxen Sodium Naproxen sodium Rite Aid Corporation ANDA Current 11822-0490 naproxen sodium Naproxen Sodium Rite Aid Corporation ANDA Current 11822-0490 naproxen sodium Naproxen Sodium Rite Aid Corporation ANDA Current 11822-0490 naproxen sodium Naproxen Sodium Rite Aid Corporation ANDA Current 11822-0490 naproxen sodium Naproxen Sodium Rite Aid Corporation ANDA Current 11822-0507 naproxen sodium Naproxen Sodium Rite Aid Corporation ANDA Current 11822-0507 naproxen sodium Naproxen Sodium Rite Aid Corporation ANDA Current 11822-0507 naproxen sodium Naproxen Sodium Rite Aid Corporation ANDA Current 11822-0507 naproxen sodium Naproxen Sodium Rite Aid Corporation ANDA Current 11822-1330 back and muscle pain Naproxen Sodium Rite Aid Corporation ANDA Current 11822-1330 back and muscle pain Naproxen Sodium Rite Aid Corporation ANDA Current 21130-016 Signature Care Pain Relief Naproxen Sodium Safeway ANDA Current 21130-016 Signature Care Pain Relief Naproxen Sodium Safeway ANDA Current 21130-180 signature care naproxen sodium Naproxen Sodium Safeway ANDA Current 21130-180 signature care naproxen sodium Naproxen Sodium Safeway ANDA Current 21130-180 signature care naproxen sodium Naproxen Sodium Safeway ANDA Current 21130-180 signature care naproxen sodium Naproxen Sodium Safeway ANDA Current 21130-187 Signature Care Naproxen Sodium Naproxen Sodium Safeway ANDA Current 21130-187 Signature Care Naproxen Sodium Naproxen Sodium Safeway ANDA Current 21130-444 Signature Care Pain Relief Naproxen Sodium Safeway ANDA Current 21130-444 Signature Care Pain Relief Naproxen Sodium Safeway ANDA Current 21130-507 signature care pain relief Naproxen sodium Safeway ANDA Current 21130-802 signature care naproxen sodium Naproxen sodium Safeway ANDA Current 21130-802 signature care naproxen sodium Naproxen sodium Safeway ANDA Current 21130-802 signature care naproxen sodium Naproxen sodium Safeway ANDA Current 21695-088 Naproxen Pain Relief Naproxen Sodium Rebel Distributors Corp ANDA Current 24385-490 Good Neighbor Pharmacy naproxen sodium Naproxen Sodium Amerisource Bergen ANDA Current 24385-490 Good Neighbor Pharmacy naproxen sodium Naproxen Sodium Amerisource Bergen ANDA Current 30142-177 Naproxen Sodium Naproxen sodium Kroger Company ANDA Current 30142-177 Naproxen Sodium Naproxen sodium Kroger Company ANDA Current 30142-177 Naproxen Sodium Naproxen sodium Kroger Company ANDA Current 30142-500 Naproxen Sodium Naproxen Sodium Kroger Company ANDA Current