Home Applications 079096 Application 079096
Type ANDA
Sponsor AMNEAL PHARMS NY 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 A079096-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16
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 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079096-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2008-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079096-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2008-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 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 1 of 2 · 31 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 2 of 2 · 138 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 53943-145 Naproxen NAPROXEN SODIUM DISCOUNT DRUG MART ANDA Current 55315-168 All Day Pain Relief Naproxen Sodium Freds Inc ANDA Current 55315-168 All Day Pain Relief Naproxen Sodium Freds Inc ANDA Current 55315-168 All Day Pain Relief Naproxen Sodium Freds Inc ANDA Current 55315-169 All Day Pain Relief Naproxen Sodium Freds Inc ANDA Current 55315-169 All Day Pain Relief Naproxen Sodium Freds Inc ANDA Current 55315-169 All Day Pain Relief Naproxen Sodium Freds Inc ANDA Current 55316-169 Naproxen Sodium Naproxen Sodium Healthy Accents (DZA Brands, LLC) ANDA Current 55316-169 Naproxen Sodium Naproxen Sodium Healthy Accents (DZA Brands, LLC) ANDA Current 55319-168 Naproxen Sodium Naproxen Sodium Family Dollar (FAMILY WELLNESS) ANDA Current 55319-168 Naproxen Sodium Naproxen Sodium Family Dollar (FAMILY WELLNESS) ANDA Current 55319-168 Naproxen Sodium Naproxen Sodium Family Dollar (FAMILY WELLNESS) ANDA Current 55319-168 Naproxen Sodium Naproxen Sodium Family Dollar (FAMILY WELLNESS) ANDA Current 55319-169 Naproxen Sodium Naproxen Sodium Family Dollar (FAMILY WELLNESS) ANDA Current 55319-169 Naproxen Sodium Naproxen Sodium Family Dollar (FAMILY WELLNESS) ANDA Current 55758-047 Rapidol Naproxen Naproxen sodium Pharmadel LLC ANDA Current 57344-144 Naproxen Sodium NAPROXEN SODIUM AAA Pharmaceutical, Inc. ANDA Current 57344-144 Naproxen Sodium NAPROXEN SODIUM AAA Pharmaceutical, Inc. ANDA Current 57344-145 Naproxen Sodium NAPROXEN SODIUM AAA Pharmaceutical, Inc. ANDA Current 57344-145 Naproxen Sodium NAPROXEN SODIUM AAA Pharmaceutical, Inc. ANDA Current 59428-068 Pain Reliever Naproxen Sodium Productos Zapotol Corp. ANDA Current 59428-068 Pain Reliever Naproxen Sodium Productos Zapotol Corp. ANDA Current 59428-168 Naproxen Sodium Naproxen Sodium Productos Zapotol Corp. ANDA Current 59428-168 Naproxen Sodium Naproxen Sodium Productos Zapotol Corp. ANDA Current 59726-168 All Day Pain Relief Naproxen Sodium P & L Development, LLC ANDA Current 59726-168 All Day Pain Relief Naproxen Sodium P & L Development, LLC ANDA Current 59726-169 All Day Pain Relief Naproxen sodium P & L Development, LLC ANDA Current 59726-169 All Day Pain Relief Naproxen sodium P & L Development, LLC ANDA Current 59726-169 All Day Pain Relief Naproxen sodium P & L Development, LLC ANDA Current 59779-172 All Day Pain Relief Naproxen Sodium CVS Pharmacy ANDA Current 61715-060 Naproxen Sodium Naproxen Sodium Kinray ANDA Current 61715-098 Naproxen Sodium NAPROXEN SODIUM Kinray LLC ANDA Current 61715-099 Naproxen Sodium NAPROXEN SODIUM Kinray LLC ANDA Current 63629-1793 Good Sense All Day Pain Relief Naproxen Sodium Bryant Ranch Prepack ANDA Current 63868-465 Naproxen Sodium NAPROXEN SODIUM Chain Drug Marketing Association ANDA Current 63868-465 Naproxen Sodium NAPROXEN SODIUM Chain Drug Marketing Association ANDA Current 63868-466 Naproxen Sodium NAPROXEN SODIUM Chain Drug Marketing Association ANDA Current 63868-466 Naproxen Sodium NAPROXEN SODIUM Chain Drug Marketing Association ANDA Current 63941-144 All Day Pain Relief NAPROXEN SODIUM VALU MERCHANDISERS COMPANY ANDA Current 63941-245 All Day Pain Relief NAPROXEN SODIUM VALU MERCHANDISERS COMPANY ANDA Current 66715-9740 Lil Drug Store Pain Relief Naproxen Sodium Lil' Drug Store Products, Inc. ANDA Current 66715-9740 Lil Drug Store Pain Relief Naproxen Sodium Lil' Drug Store Products, Inc. ANDA Current 66715-9740 Lil Drug Store Pain Relief Naproxen Sodium Lil' Drug Store Products, Inc. ANDA Current 67091-138 Naproxen Sodium NAPROXEN SODIUM WinCo Foods, LLC ANDA Current 67091-138 Naproxen Sodium NAPROXEN SODIUM WinCo Foods, LLC ANDA Current 67091-140 Naproxen Sodium NAPROXEN SODIUM WinCo Foods, LLC ANDA Current 67091-140 Naproxen Sodium NAPROXEN SODIUM WinCo Foods, LLC ANDA Current 67751-154 Flanax Pain and Fever Reliever NAPROXEN SODIUM Navajo Manufacturing Company Inc. ANDA Current 67751-154 Flanax Pain and Fever Reliever NAPROXEN SODIUM Navajo Manufacturing Company Inc. ANDA Current 67751-154 Flanax Pain and Fever Reliever NAPROXEN SODIUM Navajo Manufacturing Company Inc. ANDA Current 68998-144 NAPROXEN SODIUM NAPROXEN SODIUM Marc Glassman, Inc. ANDA Current 68998-145 NAPROXEN SODIUM NAPROXEN SODIUM Marc Glassman, Inc. ANDA Current 69469-169 Naproxen Sodium Naproxen Sodium Vitamex USA ANDA Current 69469-169 Naproxen Sodium Naproxen Sodium Vitamex USA ANDA Current 71141-116 NAPROXEN SODIUM NAPROXEN SODIUM Lidl US, LLC ANDA Current 71141-245 Naproxen Sodium NAPROXEN SODIUM LIDL US LLC ANDA Current 72036-144 Naproxen Sodium NAPROXEN SODIUM Harris Teeter ANDA Current 72036-145 Naproxen Sodium NAPROXEN SODIUM Harris Teeter ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 23929 ORIG 2009-01-06