Home Applications 074198 Application 074198
Type ANDA
Sponsor TEVA 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 A074198-001 NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 A074198-002 NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21
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 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1993-12-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1993-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074198-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 1993-12-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074198-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 1993-12-21 74a2ff9319b5…
Observed Orange Book normalized TE history# 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 · 244 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Basic Care Naproxen Sodium NAPROXEN SODIUM Amazon.com Services LLC 4bc62f12-15a5-40bd-bf99-ec15de0914c7 2024-02-15 Warnings Name fallback generic name: NAPROXEN SODIUM Medique Mediproxen NAPROXEN SODIUM A-S Medication Solutions 2d04fef4-6a26-4df2-af90-816107e7dfe2 2024-02-02 Warnings Name fallback generic name: NAPROXEN SODIUM All Day Relief NAPROXEN SODIUM Publix Supermarkets, Inc. 4db86c5b-62bb-4638-9f1e-98dc2680d6cc 2024-01-23 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever NAPROXEN SODIUM Amneal Pharmaceuticals of New York LLC 0bb41b8c-6031-4e96-95e1-31adab811837 2023-12-31 Warnings Name fallback generic name: NAPROXEN SODIUM PROXEN NP 660 NAPROXEN SODIUM OPMX LLC 09990b2f-202e-b4df-e063-6394a90a055b 2023-12-27 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Bionpharma Inc. 3e10256f-0a5f-49e4-9518-a72b10490f89 2023-12-27 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM All Day Pain Relief NAPROXEN SODIUM H E B 6dd54a14-67cd-4295-9bd5-1d6f8cb9316d 2023-12-19 Warnings Name fallback generic name: NAPROXEN SODIUM All Day Back and Muscle Pain Relief NAPROXEN SODIUM Walmart Inc. 062b9ffe-b4fc-9f5a-e063-6294a90a560e 2023-12-04 Warnings Name fallback generic name: NAPROXEN SODIUM
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.