Home Applications 040445 Application 040445
Type ANDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METAXALONE METAXALONE TABLET;ORAL 800MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040445-001 METAXALONE METAXALONE 800MG TABLET / ORAL AB 2010-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040445-001 AB
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040445-001 METAXALONE 800MG TABLET / ORAL AB 2010-03-31 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0185-0448 Metaxalone Metaxalone Eon Labs, Inc. ANDA Current 0185-0448 Metaxalone Metaxalone Eon Labs, Inc. ANDA Current 0185-0448 Metaxalone Metaxalone Eon Labs, Inc. ANDA Current 0185-0448 Metaxalone Metaxalone Eon Labs, Inc. ANDA Current 21695-585 Metaxalone Metaxalone Rebel Distributors Corp. ANDA Current 50436-0448 Metaxalone Metaxalone Unit Dose Services ANDA Current 51655-167 Metaxalone Metaxalone Northwind Pharmaceuticals ANDA Current 60760-155 Metaxalone Metaxalone St. Mary's Medical Park Pharmacy ANDA Current 61919-091 METAXALONE METAXALONE DIRECT RX ANDA Current 61919-091 METAXALONE METAXALONE DIRECT RX ANDA Current 67296-1275 Metaxalone Metaxalone RedPharm Drug, Inc. ANDA Current 67296-1275 Metaxalone Metaxalone RedPharm Drug, Inc. ANDA Current 67296-1275 Metaxalone Metaxalone RedPharm Drug, Inc. ANDA Current 68788-6466 Metaxalone Metaxalone Preferred Pharmaceuticals Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22144 SUPPL 2013-05-14 22143 ORIG 2013-01-28 7663 ORIG 2010-04-05