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 5 of 13 · 252 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen Sodium NAPROXEN SODIUM Chain Drug Marketing Association 2ee83008-c012-48d6-9479-65e7d6f50f4c 2025-12-10 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM TARGET Corporation 36bf8594-9303-c816-e063-6294a90af705 2025-12-08 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Aleve Headache Pain NAPROXEN SODIUM Bayer HealthCare LLC c69f4926-c5cd-63a0-e053-2a95a90a2ca6 2025-12-04 Warnings Name fallback generic name: NAPROXEN SODIUM Aleve NAPROXEN SODIUM Bayer HealthCare LLC. 00ef5b30-71d0-4cb4-84a3-48c67d1cea2a 2025-12-04 Name fallback generic name: NAPROXEN SODIUM Aleve Back and Muscle Pain NAPROXEN SODIUM Bayer HealthCare LLC. 6376e1b8-52c4-0519-e053-2a91aa0af35f 2025-12-04 Name fallback generic name: NAPROXEN SODIUM Aleve Caplets NAPROXEN SODIUM Bayer HealthCare LLC. a3745850-3e32-4884-b315-161bcb9996ed 2025-12-04 Name fallback generic name: NAPROXEN SODIUM Aleve Gelcaps NAPROXEN SODIUM Bayer HealthCare LLC. acea54a2-5a92-428e-a778-bb4f9d676782 2025-12-04 Name fallback generic name: NAPROXEN SODIUM Aleve Gelcaps NAPROXEN SODIUM Bayer HealthCare LLC. 0ad8bbb9-dd5f-4273-b085-ee3e5ed22613 2025-12-04 Warnings Name fallback generic name: NAPROXEN SODIUM Aleve Easy Open Arthritis Cap NAPROXEN SODIUM Bayer HealthCare LLC. 3c0ddd25-5a9a-4628-a971-65fe2a9775b5 2025-12-04 Warnings Name fallback generic name: NAPROXEN SODIUM Aleve NAPROXEN SODIUM Bayer HealthCare LLC. 1266393e-b55e-4e34-9710-0b87209f4158 2025-12-04 Warnings Name fallback generic name: NAPROXEN SODIUM Aleve Easy Open Arthritis Cap NAPROXEN SODIUM Bayer HealthCare LLC. 3b5442c6-c6e1-4df3-8cec-40bbb4ec469f 2025-12-04 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM Granules India Ltd 1f8da545-bcfe-4c22-a9f1-d34108120aa0 2025-12-01 Boxed warning, Warnings, Adverse reactions Name fallback generic name: NAPROXEN SODIUM CAREALL Naproxen NAPROXEN SODIUM New World Imports, Inc. d9a0c6e7-a70e-479a-9737-e81a2887c778 2025-12-01 Warnings Name fallback generic name: NAPROXEN SODIUM CAREALL Naproxen Sodium NAPROXEN SODIUM New World Imports, Inc. 3952324e-77f4-4117-a97a-ab5651130058 2025-12-01 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Upsher-Smith Laboratories, LLC 7c22a2d6-821c-4f83-aead-e756aed930e5 2025-12-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM up and up naproxen sodium NAPROXEN SODIUM Target Corporation b0e98603-94e9-474a-88a0-22042f461271 2025-11-19 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Bryant Ranch Prepack 0e7697ad-25c6-4405-9f9b-791633cb1ef7 2025-11-18 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM P & L Development, LLC 3bd60171-c073-441a-8d59-c85efee69e07 2025-11-17 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Aleve NAPROXEN SODIUM R J General Corporation 46e7b298-9e19-49b6-be71-e4fdcb09a5d4 2025-11-17 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Athlete's Needs Inc d5984c9d-3941-45d6-8392-87564b2faae0 2025-11-15 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 · 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