Home Applications 075280 Application 075280
Type ANDA
Sponsor CASI PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NABUMETONE NABUMETONE TABLET;ORAL 500MG No No 002 NABUMETONE NABUMETONE TABLET;ORAL 750MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A075280-001 NABUMETONE NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 A075280-002 NABUMETONE NABUMETONE 750MG TABLET / ORAL AB 2002-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nabumetone NABUMETONE Chartwell RX, LLC 84bb2887-bab4-46ae-a07c-fa2a32c04b50 2023-01-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075280 application number: ANDA075280
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 23 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0185-0145 Nabumetone Nabumentone Eon Labs, Inc. ANDA Current 0185-0146 Nabumetone Nabumentone Eon Labs, Inc. ANDA Current 35356-685 Nabumetone Nabumentone Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-685 Nabumetone Nabumentone Lake Erie Medical DBA Qua ANDA Current 55289-609 Nabumetone Nabumentone PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-609 Nabumetone Nabumentone PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-609 Nabumetone Nabumentone PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-609 Nabumetone Nabumentone PD-Rx Pharmaceuticals, Inc. ANDA Current 60760-184 Nabumetone Nabumentone St. Mary's Medical Park Pharmacy ANDA Current 60760-185 Nabumetone Nabumetone St. Mary's Medical Park Pharmacy ANDA Current 61919-609 NABUMETONE NABUMETONE DIRECT RX ANDA Current 68084-051 Nabumetone Nabumentone American Health Packaging ANDA Current 70518-0614 Nabumetone Nabumentone REMEDYREPACK INC. ANDA Current 70518-0614 Nabumetone Nabumentone REMEDYREPACK INC. ANDA Current 70518-0698 Nabumetone Nabumentone REMEDYREPACK INC. ANDA Current 70518-0698 Nabumetone Nabumentone REMEDYREPACK INC. ANDA Current 71205-378 Nabumetone Nabumentone Proficient Rx LP ANDA Current 71335-0754 Nabumetone Nabumentone Bryant Ranch Prepack ANDA Current 71335-0754 Nabumetone Nabumentone Bryant Ranch Prepack ANDA Current 71335-0781 Nabumetone Nabumentone Bryant Ranch Prepack ANDA Current 71335-0781 Nabumetone Nabumentone Bryant Ranch Prepack ANDA Current 71335-0939 Nabumetone Nabumentone Bryant Ranch Prepack ANDA Current 71335-0939 Nabumetone Nabumentone Bryant Ranch Prepack ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8595 ORIG 2004-06-09 8596 ORIG 2003-04-10