Home Applications 204770 Application 204770
Type ANDA
Sponsor LANNETT CO INC 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 43 .
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 A204770-001 METAXALONE METAXALONE 800MG TABLET / ORAL AB 2016-11-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204770-001 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 · 43 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 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 2 of 2 · 21 matching rows.
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 · 54 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0527-1435 Metaxalone Metaxalone Lannett Company, Inc. ANDA Current 0527-1435 Metaxalone Metaxalone Lannett Company, Inc. ANDA Current 0527-1435 Metaxalone Metaxalone Lannett Company, Inc. ANDA Current 0527-1435 Metaxalone Metaxalone Lannett Company, Inc. ANDA Current 45865-942 Metaxalone Metaxalone medsource pharmaceuticals ANDA Current 50090-3650 Metaxalone Metaxalone A-S Medication Solutions ANDA Current 50090-3650 Metaxalone Metaxalone A-S Medication Solutions ANDA Current 50090-3650 Metaxalone Metaxalone A-S Medication Solutions ANDA Current 50090-3650 Metaxalone Metaxalone A-S Medication Solutions ANDA Current 50090-3650 Metaxalone Metaxalone A-S Medication Solutions ANDA Current 50090-3670 Metaxalone Metaxalone A-S Medication Solutions ANDA Current 50090-3670 Metaxalone Metaxalone A-S Medication Solutions ANDA Current 55700-494 Metaxalone Metaxalone Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-494 Metaxalone Metaxalone Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-494 Metaxalone Metaxalone Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-494 Metaxalone Metaxalone Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-494 Metaxalone Metaxalone Lake Erie Medical DBA Quality Care Products LLC ANDA Current 60760-289 Metaxalone Metaxalone St. Mary's Medical Park Pharmacy ANDA Current 60760-289 Metaxalone Metaxalone St. Mary's Medical Park Pharmacy ANDA Current 60760-289 Metaxalone Metaxalone St. Mary's Medical Park Pharmacy ANDA Current 61919-832 METAXALONE METAXALONE DIRECT RX ANDA Current 61919-832 Metaxalone Metaxalone Direct_Rx ANDA Current 61919-832 Metaxalone Metaxalone Direct_Rx ANDA Current 61919-832 METAXALONE METAXALONE DIRECT RX ANDA Current 61919-832 METAXALONE METAXALONE DIRECT RX ANDA Current 63629-2097 Metaxalone Metaxalone Bryant Ranch Prepack ANDA Current 63629-2097 Metaxalone Metaxalone Bryant Ranch Prepack ANDA Current 68071-2849 Metaxalone Metaxalone NuCare Pharmaceuticals,Inc. ANDA Current 68788-7675 Metaxalone Metaxalone Preferred Pharmaceuticals, Inc. ANDA Current 68788-7675 Metaxalone Metaxalone Preferred Pharmaceuticals, Inc. ANDA Current 68788-7675 Metaxalone Metaxalone Preferred Pharmaceuticals, Inc. ANDA Current 69306-311 Metaxalone Metaxalone Doc Rx ANDA Current 70332-330 Metaxalone Metaxalone California Pharmaceuticals, LLC ANDA Current 70518-0771 Metaxalone Metaxalone REMEDYREPACK INC. ANDA Current 70518-0771 Metaxalone Metaxalone REMEDYREPACK INC. ANDA Current 70518-0771 Metaxalone Metaxalone REMEDYREPACK INC. ANDA Current 70518-0771 Metaxalone Metaxalone REMEDYREPACK INC. ANDA Current 70518-0771 Metaxalone Metaxalone REMEDYREPACK INC. ANDA Current 70934-286 Metaxalone Metaxalone Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-286 Metaxalone Metaxalone Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-286 Metaxalone Metaxalone Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 71205-426 Metaxalone Metaxalone Proficient Rx LP ANDA Current 71205-426 Metaxalone Metaxalone Proficient Rx LP ANDA Current 71205-426 Metaxalone Metaxalone Proficient Rx LP ANDA Current 71335-0958 Metaxalone Metaxalone Bryant Ranch Prepack ANDA Current 71335-0958 Metaxalone Metaxalone Bryant Ranch Prepack ANDA Current 71335-0958 Metaxalone Metaxalone Bryant Ranch Prepack ANDA Current 71335-1696 Metaxalone Metaxalone Bryant Ranch Prepack ANDA Current 71335-1696 Metaxalone Metaxalone Bryant Ranch Prepack ANDA Current 71335-2066 Metaxalone Metaxalone Bryant Ranch Prepack ANDA Current 76420-232 Metaxalone Metaxalone Asclemed USA, Inc. ANDA Current 80425-0122 Skelaxin Metaxalone 800mg Advanced Rx Pharmacy of Tennessee, LLC ANDA Current 80425-0122 Metaxalone Metaxalone Advanced Rx Pharmacy of Tennessee, LLC ANDA Current 80425-0122 Metaxalone Metaxalone Advanced Rx Pharmacy of Tennessee, LLC ANDA Current