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 10 of 13 · 252 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join exchange select naproxen sodium NAPROXEN SODIUM Army & Air Force Exchange Service 5294f434-62c2-4393-9c9e-c94dd9a19687 2024-12-07 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM WinCo Foods, LLC 44ef3ef4-9495-4a63-92f0-f0ab19c4ec23 2024-12-06 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM WinCo Foods, LLC 074fc2b9-743b-458e-a0c0-d5f27633bbf3 2024-12-06 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM All Day Pain Relief NAPROXEN SODIUM VALU MERCHANDISERS COMPANY 48059718-4e35-479c-a549-ac534d3ba899 2024-12-04 Warnings Name fallback generic name: NAPROXEN SODIUM All Day Pain Relief NAPROXEN SODIUM VALU MERCHANDISERS COMPANY 593b915f-045a-40b7-b86e-0d1cb41f2bb8 2024-12-04 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Teva Pharmaceuticals, Inc. 826fd9e3-22fe-408b-820c-f2b710189555 2024-12-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Belmora Flanax NAPROXEN SODIUM Belmora LLC a44b8a82-251d-d5e8-e053-2a95a90a72f7 2024-10-08 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Albertsons Companies f9df7495-9da7-8838-e053-6294a90a6fda 2024-09-30 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen sodium NAPROXEN SODIUM Bryant Ranch Prepack 42f6a3a0-5a1e-40ca-8949-b8870dd95d2e 2024-08-12 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Alvogen Inc. 9225acaa-209f-958b-2c51-9a46995dec33 2024-07-15 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naprelan NAPROXEN SODIUM Almatica Pharma LLC e633ff0b-eab7-f167-8d08-e9236e54042b 2024-07-15 Boxed warning, Warnings, Adverse reactions Name fallback generic name: NAPROXEN SODIUM Aleve liquid gels NAPROXEN SODIUM Bayer Healthcare LLC a0587c73-d297-462d-a0ef-750cb324486e 2024-05-06 Warnings Name fallback generic name: NAPROXEN SODIUM Topcare All Day Pain Relief NAPROXEN SODIUM Topco Associates LLC f151d48d-a8f7-484e-9ce8-6b2e8dd1093f 2024-04-25 Warnings Name fallback generic name: NAPROXEN SODIUM naproxen sodium NAPROXEN SODIUM H E B 535a6531-3372-4206-b97b-f26a16b6d80c 2024-04-25 Warnings Name fallback brand name: naproxen sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM AMERISOURCE BERGEN 16b3bbee-4881-b439-e063-6394a90a7c8f 2024-04-22 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Lil Drug Store Pain Relief All Day NAPROXEN SODIUM Lil' Drug Store Products, Inc. 41d2d995-47ef-419d-8e57-ea3f9f8a9f68 2024-03-29 Warnings Name fallback generic name: NAPROXEN SODIUM ALL DAY PAIN RELIEF NAPROXEN SODIUM WALGREENS 8771b84f-47bf-116c-e053-2995a90a0aad 2024-03-15 Warnings Name fallback generic name: NAPROXEN SODIUM ALL DAY PAIN RELIEF NAPROXEN SODIUM WALGREENS 8771300f-e907-3d53-e053-2a95a90ae402 2024-03-15 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Care One (Retail Business Services, LLC.) 5582d6e1-4937-43f6-a92c-9d5f9ef1a3ad 2024-02-21 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM good sense naproxen sodium NAPROXEN SODIUM L. Perrigo Company a980b939-f74d-4e95-87a8-65ad5a783ac5 2024-02-19 Warnings Name fallback 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 · 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