Application 021447

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	CAPSULE;ORAL	EQ 2MG BASE	Yes	No
002	ZANAFLEX	TIZANIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 4MG BASE	Yes	No
003	ZANAFLEX	TIZANIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 6MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021447-001	ZANAFLEX	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29
N021447-002	ZANAFLEX	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29
N021447-003	ZANAFLEX	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021447-001	AB
N021447-002	AB
N021447-003	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 4 · 126 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	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021447-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021447-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021447-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021447-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021447-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021447-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021447-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021447-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021447-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021447-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021447-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021447-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021447-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021447-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021447-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021447-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021447-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021447-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021447-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021447-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021447-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021447-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021447-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021447-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021447-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021447-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021447-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021447-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021447-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021447-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021447-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021447-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021447-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021447-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021447-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021447-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021447-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021447-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021447-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021447-001	AB	1	`1e350fbaab3a…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zanaflex	TIZANIDINE HYDROCHLORIDE	Legacy Pharma USA, Inc.	60c27d35-7349-4fc6-86ad-70fffdbe3e08	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021447 application number: NDA021447
Zanaflex	TIZANIDINE HYDROCHLORIDE	Covis Pharma US, Inc	043d9e51-bfa2-4add-9058-5ece332f7e99	2025-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021447 application number: NDA021447 ndc (product): 70515-604 ndc (product): 70515-606 ndc (product): 70515-602
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	cb8b01b3-bcec-4762-9d67-0db018ef6b22	2023-03-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021447 application number: NDA021447 ndc (product): 0591-2789 ndc (product): 0591-2790 ndc (product): 0591-2788

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2788	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2788	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2788	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2788	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2788	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2789	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2789	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2789	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2789	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2789	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2790	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2790	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2790	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2790	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2790	tizanidine hydrochloride	tizanidine hydrochloride	Actavis Pharma, Inc.	NDA	Current
10144-602	Zanaflex	tizanidine hydrochloride	Acorda Therapeutics, Inc.	NDA	Current
10144-604	Zanaflex	tizanidine hydrochloride	Acorda Therapeutics, Inc.	NDA	Current
10144-606	Zanaflex	tizanidine hydrochloride	Acorda Therapeutics, Inc.	NDA	Current
21695-373	Zanaflex	tizanidine hydrochloride	Rebel Distributors Corp	NDA	Current
55700-259	tizanidine hydrochloride	tizanidine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
55700-259	tizanidine hydrochloride	tizanidine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
63629-5139	tizanidine hydrochloride	tizanidine hydrochloride	Bryant Ranch Prepack	NDA	Current
63629-5139	tizanidine hydrochloride	tizanidine hydrochloride	Bryant Ranch Prepack	NDA	Current
70515-602	Zanaflex	tizanidine hydrochloride	Covis Pharma US, Inc	NDA	Current
70515-602	Zanaflex	tizanidine hydrochloride	Covis Pharma	NDA	Current
70515-602	Zanaflex	tizanidine hydrochloride	Covis Pharma	NDA	Current
70515-604	Zanaflex	tizanidine hydrochloride	Covis Pharma US, Inc	NDA	Current
70515-604	Zanaflex	tizanidine hydrochloride	Covis Pharma	NDA	Current
70515-604	Zanaflex	tizanidine hydrochloride	Covis Pharma	NDA	Current
70515-606	Zanaflex	tizanidine hydrochloride	Covis Pharma US, Inc	NDA	Current
70515-606	Zanaflex	tizanidine hydrochloride	Covis Pharma	NDA	Current
70515-606	Zanaflex	tizanidine hydrochloride	Covis Pharma	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80332	SUPPL	2025-01-21
80433	SUPPL	2024-11-26
65690	SUPPL	2020-12-22
65669	SUPPL	2020-12-22
36966	SUPPL	2013-11-08
27827	SUPPL	2013-11-08
5419	SUPPL	2013-03-11
15505	SUPPL	2006-08-04
5418	SUPPL	2006-08-04
21667	ORIG	2004-03-24
27826	ORIG	2003-05-30
15504	ORIG	2002-08-29