Home Applications 020397 Application 020397
Type NDA
Sponsor COVIS PHARMA BV Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZANAFLEX TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Yes Yes 002 ZANAFLEX TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No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 42 .
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 N020397-001 ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 N020397-002 ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020397-001 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 3 · 84 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 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020397-002 ZANAFLEX EQ 2MG BASE TABLET / ORAL RLD 2000-02-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020397-002 ZANAFLEX EQ 2MG BASE TABLET / ORAL RLD 2000-02-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 2000-02-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 bb7c543d1eb4…
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10144-594 Zanaflex tizanidine hydrochloride Acorda Therapeutics, Inc. NDA Current 55289-612 Zanaflex tizanidine hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 55289-612 Zanaflex tizanidine hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 55289-612 Zanaflex tizanidine hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 70515-594 Zanaflex tizanidine hydrochloride Covis Pharma US, Inc NDA Current 70515-594 Zanaflex tizanidine hydrochloride Covis Pharma NDA Current 70515-594 Zanaflex tizanidine hydrochloride Covis Pharma NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 80331 SUPPL 2025-01-21 80432 SUPPL 2024-11-26 78621 SUPPL 2024-06-04 78610 SUPPL 2024-06-03 24904 SUPPL 2013-11-08 12535 SUPPL 2013-11-08 24903 SUPPL 2013-03-21 41331 SUPPL 2007-07-09 12534 SUPPL 2006-08-04 2474 SUPPL 2006-08-04 24902 SUPPL 2002-11-27 57447 ORIG 1997-04-11