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 3 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 CVS Pharmacy efe4352f-856b-4ada-8bd4-0a78423447dc 2026-02-27 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM L.N.K. International, Inc. 717518e4-2537-4229-b765-c6acfe963d4b 2026-02-25 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen sodium NAPROXEN SODIUM PHOENIX RX LLC 47d18804-d8d6-8248-e063-6394a90a48a9 2026-02-24 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Better Living Brands, LLC 3eeb07fe-fcf1-4ea7-b0c2-9cb04f88c041 2026-02-13 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Advanced Rx of Tennessee, LLC 369911ea-9069-9c45-e063-6394a90a5ce6 2026-02-12 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Advanced Rx of Tennessee, LLC 36996557-3227-b753-e063-6394a90a7b6f 2026-02-12 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Topcare All Day Pain Relief NAPROXEN SODIUM Topco Associates LLC 7f1cda40-9a67-4de1-af56-ab881c6354c4 2026-02-11 Warnings Name fallback generic name: NAPROXEN SODIUM naproxen sodium NAPROXEN SODIUM H E B 2f9439bb-e808-4c54-ba61-f75f117c8b37 2026-02-11 Warnings Name fallback brand name: naproxen sodium generic name: NAPROXEN SODIUM Back and Muscle Pain NAPROXEN SODIUM Rite Aid Corporation e162bd50-f94a-4c76-8f1b-62114f283809 2026-02-11 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Padagis Israel Pharmaceuticals Ltd cdb60f74-ce23-4015-90eb-b23a2275f6cb 2026-02-11 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen sodium NAPROXEN SODIUM A-S Medication Solutions 8181bb7a-d917-4388-bcb0-a74671b07b06 2026-02-10 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Bryant Ranch Prepack 83dd8829-7ba0-4a8d-a979-41a5e077c49f 2026-02-09 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM topcare back and muscle pain NAPROXEN SODIUM Topco Associates LLC de587e8f-38f2-4e7a-8e6a-64e48f280c4f 2026-02-07 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Meijer Distribution Inc db87d1da-8507-4bbf-aefc-3dbd48cde26b 2026-02-05 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Advanced Rx of Tennessee, LLC 4a05ca8c-1b03-fa86-e063-6394a90a4119 2026-02-04 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Rugby All Day Relief NAPROXEN SODIUM Bryant Ranch Prepack 3238dfdc-82d1-4afb-b27c-0ba0a5d24744 2026-02-04 Warnings Name fallback generic name: NAPROXEN SODIUM Good Sense Naproxen Sodium NAPROXEN SODIUM L. Perrigo Company 6bc74cda-458c-480e-a33c-d2ba68d5e6bd 2026-01-29 Warnings Name fallback generic name: NAPROXEN SODIUM Care One Naproxen Sodium NAPROXEN SODIUM American Sales Company bc5ddcf2-640c-4683-a60f-ca1c8b418873 2026-01-29 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Bryant Ranch Prepack 1c2325f7-1d65-429d-a64d-6ab075df1c20 2026-01-28 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Flanax Menstrual Pain Reliever NAPROXEN SODIUM Belmora LLC 2b4135b3-389c-46e2-ae86-7674c2ab9a32 2026-01-27 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