Home Applications 022503 Application 022503
Type NDA
Sponsor PRIMUS PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METAXALONE METAXALONE TABLET;ORAL 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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date N022503-001 METAXALONE METAXALONE 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, RS 2015-06-01
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022503-001 11918559 2039-07-29 Drug product 2024-03-13 N022503-001 12485111 2043-05-14 U-4453 Drug product 2026-04-10
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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 N022503-001 METAXALONE 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2015-06-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022503-001 METAXALONE 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2015-06-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022503-001 METAXALONE 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2015-06-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022503-001 METAXALONE 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, RS 2015-06-01 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022503-001 12485111 2043-05-14 U-4453 Drug product 2026-04-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022503-001 12485111 2043-05-14 U-4453 Drug product 2026-04-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022503-001 12485111 2043-05-14 U-4453 Drug product 2026-04-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022503-001 11918559 2039-07-29 Drug product 2024-03-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022503-001 12485111 2043-05-14 U-4453 Drug product 2026-04-10 a50c72e98297…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 82196 SUPPL 2025-05-15 82256 SUPPL 2025-05-08 77229 SUPPL 2024-01-17 77207 SUPPL 2024-01-11 70320 SUPPL 2022-03-01 70286 SUPPL 2022-02-28 42541 ORIG 2015-12-09 24326 ORIG 2015-12-09 29788 ORIG 2015-06-09 17650 ORIG 2015-06-04