Home Applications 078620 Application 078620
Type ANDA
Sponsor ZYDUS PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NAPROXEN NAPROXEN TABLET;ORAL 250MG No No 002 NAPROXEN NAPROXEN TABLET;ORAL 375MG No No 003 NAPROXEN NAPROXEN TABLET;ORAL 500MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078620-001 NAPROXEN NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 A078620-002 NAPROXEN NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 A078620-003 NAPROXEN NAPROXEN 500MG TABLET / ORAL AB 2007-06-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 129 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 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 8 of 8 · 141 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen NAPROXEN NCS HealthCare of KY, Inc dba Vangard Labs 62a12771-bde9-4bc3-9ce9-672c8e31f020 2017-10-12 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen generic name: NAPROXEN
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 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65841-676 Naproxen Naproxen Cadila Healthcare Limited ANDA Current 65841-676 Naproxen Naproxen Zydus Lifesciences Limited ANDA Current 65841-676 Naproxen Naproxen Cadila Healthcare Limited ANDA Current 65841-676 Naproxen Naproxen Cadila Healthcare Limited ANDA Current 65841-677 Naproxen Naproxen Cadila Healthcare Limited ANDA Current 65841-677 Naproxen Naproxen Zydus Lifesciences Limited ANDA Current 65841-677 Naproxen Naproxen Cadila Healthcare Limited ANDA Current 65841-677 Naproxen Naproxen Cadila Healthcare Limited ANDA Current 65841-678 Naproxen Naproxen Cadila Healthcare Limited ANDA Current 65841-678 Naproxen Naproxen Zydus Lifesciences Limited ANDA Current 65841-678 Naproxen Naproxen Cadila Healthcare Limited ANDA Current 65841-678 Naproxen Naproxen Cadila Healthcare Limited ANDA Current 68382-012 Naproxen Naproxen Zydus Pharmaceuticals USA Inc. ANDA Current 68382-012 Naproxen Naproxen Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-012 Naproxen Naproxen Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-013 Naproxen Naproxen Zydus Pharmaceuticals USA Inc. ANDA Current 68382-013 Naproxen Naproxen Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-013 Naproxen Naproxen Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-014 Naproxen Naproxen Zydus Pharmaceuticals USA Inc. ANDA Current 68382-014 Naproxen Naproxen Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-014 Naproxen Naproxen Zydus Pharmaceuticals (USA) Inc. ANDA Current