Home Applications 078432 Application 078432
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 EQ 250MG BASE No No 002 NAPROXEN SODIUM NAPROXEN SODIUM TABLET;ORAL EQ 500MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078432-001 NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 A078432-002 NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25
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 3 · 86 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 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
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 6 of 13 · 252 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join up and up naproxen sodium NAPROXEN SODIUM Target Corporation 00bd8490-f280-4336-b13d-0e11c0bf4586 2025-11-04 Warnings Name fallback generic name: NAPROXEN SODIUM Rugby All Day Relief NAPROXEN SODIUM Rugby Laboratories 16e107f0-45a3-428f-b849-0f20a848a602 2025-10-30 Warnings Name fallback generic name: NAPROXEN SODIUM Leader All Day Pain Relief NAPROXEN SODIUM Cardinal Health 110, LLC. dba Leader b01c2b4e-a092-42dc-a387-d181d8ba14bb 2025-10-30 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM Better Living Brands, LLC 43745d42-f859-4168-a2dd-2c8ae47ae590 2025-10-28 Warnings Name fallback generic name: NAPROXEN SODIUM CALMADOL PAIN RELIEVER NAPROXEN SODIUM GRANDALL DISTRIBUTING, LLC 8edec8d1-a323-436b-8329-c327438516e3 2025-10-28 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM Family Dollar Services Inc b6205032-f5c6-494a-8b87-adbbbc3982e7 2025-10-27 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM Amerisource Bergen 1e2e6e3a-b095-4d5b-86fe-61eb44a87cf0 2025-10-20 Warnings Name fallback generic name: NAPROXEN SODIUM First Aid Direct All Day Pain Relief NAPROXEN SODIUM Cintas Corporation 1c9384c1-52f8-4482-88fc-5f5b6d770c42 2025-09-22 Warnings Name fallback generic name: NAPROXEN SODIUM foster and thrive all day pain relief NAPROXEN SODIUM Strategic Sourcing Services LLC 01746bb6-4068-4737-ba38-04cd5f1a81ba 2025-09-12 Warnings Name fallback generic name: NAPROXEN SODIUM Bayer Aleve NAPROXEN SODIUM Unifirst First Aid Corporation 5dd569ca-d03e-410c-af98-4732c823d595 2025-09-09 Warnings Name fallback generic name: NAPROXEN SODIUM Medique at Home Mediproxen NAPROXEN SODIUM Unifirst First Aid Corporation b591ba4f-d7d3-4c81-e053-2995a90a7c6e 2025-09-09 Warnings Name fallback generic name: NAPROXEN SODIUM Medique Mediproxen NAPROXEN SODIUM Unifirst First Aid Corporation f6261d45-df1f-483b-b013-3cd6f78d9d43 2025-09-08 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Aurobindo Pharma Limited 37b264f9-b46d-4635-8fab-246b1e08b653 2025-09-05 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Good Sense Naproxen Sodium NAPROXEN SODIUM Bryant Ranch Prepack e5e8768d-c6e0-4018-b788-5ce86929f7b0 2025-08-26 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium PM NAPROXEN SODIUM Strategic Sourcing Services LLC 03a331d8-c957-4949-894f-51d9bd15e0d0 2025-08-20 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM P & L Development, LLC fc65fe79-c93b-4247-b9af-e562792a3e64 2025-08-19 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM NAPROXEN SODIUM NAPROXEN SODIUM Safeway 396f4e60-3dde-433f-b4b5-25f351c96d57 2025-08-19 Warnings Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Preferred Pharmaceuticals, Inc. 6ae413ba-5a48-423f-8b8d-7a42661cf836 2025-08-18 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Dr Simi All Day Pain Relief NAPROXEN SODIUM Farmacias De Similares TX LLC 3c6d4bb5-eb6f-944b-e063-6294a90ae8de 2025-08-15 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM 220MG CVS Pharmacy, Inc. 1fde52e7-7a7f-40e8-e063-6394a90a922a 2025-08-11 Warnings Name fallback brand 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 · 67 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10544-128 Naproxen Sodium Naproxen Sodium Blenheim Pharmacal, Inc. ANDA Current 17856-0194 Naproxen Sodium Naproxen Sodium Atlantic Biologicals Corps ANDA Current 21695-090 Naproxen Sodium Naproxen Sodium Rebel Distributors Corp ANDA Current 33261-084 Naproxen Sodium Naproxen Sodium Aidarex Pharmaceuticals LLC ANDA Current 33261-085 Naproxen Sodium Naproxen Sodium Aidarex Pharmaceuticals LLC ANDA Current 33358-259 Naproxen Sodium Naproxen Sodium RxChange Co. ANDA Current 42291-516 NAPROXEN SODIUM NAPROXEN SODIUM AvKARE, Inc. ANDA Current 42291-516 NAPROXEN SODIUM NAPROXEN SODIUM AvKARE, Inc. ANDA Current 42291-516 NAPROXEN SODIUM NAPROXEN SODIUM AvKARE ANDA Current 42291-517 NAPROXEN SODIUM NAPROXEN SODIUM AvKARE, Inc. ANDA Current 42291-517 NAPROXEN SODIUM NAPROXEN SODIUM AvKARE, Inc. ANDA Current 42291-517 NAPROXEN SODIUM NAPROXEN SODIUM AvKARE ANDA Current 42291-531 Naproxen Sodium Naproxen Sodium AvKARE, Inc. ANDA Current 42291-531 Naproxen Sodium Naproxen Sodium AvKARE, Inc. ANDA Current 42291-532 Naproxen Sodium Naproxen Sodium AvKARE, Inc. ANDA Current 42291-532 Naproxen Sodium Naproxen Sodium AvKARE, Inc. ANDA Current 45865-349 Naproxen Sodium Naproxen Sodium Medsource Pharmaceuticals ANDA Current 50268-592 Naproxen Sodium Naproxen Sodium AvPAK ANDA Current 50268-592 Naproxen Sodium Naproxen Sodium AvPAK ANDA Current 50268-592 Naproxen Sodium Naproxen Sodium AvPAK ANDA Current 50268-593 Naproxen Sodium Naproxen Sodium AvPAK ANDA Current 50268-593 Naproxen Sodium Naproxen Sodium AvPAK ANDA Current 50268-593 Naproxen Sodium Naproxen Sodium AvPAK ANDA Current 50436-6613 Naproxen Sodium Naproxen Sodium Unit Dose Services ANDA Current 51655-627 Naproxen Sodium Naproxen Northwind Pharmaceuticals, LLC ANDA Current 53746-193 Naproxen Sodium Naproxen Sodium Amneal Pharmaceuticals of New York LLC ANDA Current 53746-193 Naproxen Sodium Naproxen Sodium Amneal Pharmaceuticals of New York LLC ANDA Current 53746-193 Naproxen Sodium Naproxen Sodium Amneal Pharmaceuticals of New York LLC ANDA Current 53746-193 Naproxen Sodium Naproxen Sodium Amneal Pharmaceuticals of New York LLC ANDA Current 53746-193 Naproxen Sodium Naproxen Sodium Amneal Pharmaceuticals of New York LLC ANDA Current 53746-193 Naproxen Sodium Naproxen Sodium Amneal Pharmaceuticals of New York LLC ANDA Current 53746-194 Naproxen Sodium Naproxen Sodium Amneal Pharmaceuticals of New York LLC ANDA Current 53746-194 Naproxen Sodium Naproxen Sodium Amneal Pharmaceuticals of New York LLC ANDA Current 53746-194 Naproxen Sodium Naproxen Sodium Amneal Pharmaceuticals of New York LLC ANDA Current 53746-194 Naproxen Sodium Naproxen Sodium Amneal Pharmaceuticals of New York LLC ANDA Current 53746-194 Naproxen Sodium Naproxen Sodium Amneal Pharmaceuticals of New York LLC ANDA Current 53746-194 Naproxen Sodium Naproxen Sodium Amneal Pharmaceuticals of New York LLC ANDA Current 53808-0872 Naproxen Sodium Naproxen Sodium State of Florida DOH Central Pharmacy ANDA Current 55289-367 Naproxen Sodium Naproxen Sodium PD-Rx Pharmaceuticals, In ANDA Current 55289-367 Naproxen Sodium Naproxen Sodium PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-367 Naproxen Sodium Naproxen Sodium PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-367 Naproxen Sodium Naproxen Sodium PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-367 Naproxen Sodium Naproxen Sodium PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-367 Naproxen Sodium Naproxen Sodium PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-367 Naproxen Sodium Naproxen Sodium PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-367 Naproxen Sodium Naproxen Sodium PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-367 Naproxen Sodium Naproxen Sodium PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-367 Naproxen Sodium Naproxen Sodium PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-367 Naproxen Sodium Naproxen Sodium PD-Rx Pharmaceuticals, Inc. ANDA Current 55700-073 Naproxen Sodium Naproxen Sodium Lake Erie Medical DBA Quality Care Products LLC ANDA Current 58517-300 Naproxen Sodium Naproxen Sodium New Horizon Rx Group, LLC ANDA Current 61919-165 NAPROXEN SODIUM NAPROXEN SODIUM DIRECT RX ANDA Current 61919-165 NAPROXEN SODIUM NAPROXEN SODIUM DIRECT RX ANDA Current 63187-121 Naproxen Sodium Naproxen Sodium Proficient Rx LP ANDA Current 63187-121 Naproxen Sodium Naproxen Sodium Proficient Rx LP ANDA Current 63629-1260 Naproxen Sodium Naproxen Sodium Bryant Ranch Prepack ANDA Current 63629-1260 Naproxen Sodium Naproxen Sodium Bryant Ranch Prepack ANDA Current 66267-154 Naproxen Sodium Naproxen Sodium NuCare Pharmaceuticals, Inc. ANDA Current 66267-154 Naproxen Sodium Naproxen Sodium NuCare Pharmaceuticals, Inc. ANDA Current 68387-545 Naproxen Sodium Naproxen Sodium Keltman Pharmaceuticals Inc. ANDA Current 68788-9022 Naproxen Sodium Naproxen Sodium Preferred Pharmaceuticals, Inc. ANDA Current 70518-0724 Naproxen Sodium Naproxen Sodium REMEDYREPACK INC. ANDA Current 70518-0724 Naproxen Sodium Naproxen Sodium REMEDYREPACK INC. ANDA Current 70518-0724 Naproxen Sodium Naproxen Sodium REMEDYREPACK INC. ANDA Current 70518-0724 Naproxen Sodium Naproxen Sodium REMEDYREPACK INC. ANDA Current 70518-0724 Naproxen Sodium Naproxen Sodium REMEDYREPACK INC. ANDA Current 70518-0724 Naproxen Sodium Naproxen Sodium REMEDYREPACK INC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 23906 ORIG 2007-05-08