Application 078868

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 2MG BASE	No	No
002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 4MG BASE	No	No
003	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 6MG BASE	No	No

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	Approval date
A078868-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03
A078868-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03
A078868-003	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078868-001	AB
A078868-002	AB
A078868-003	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078868-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2012-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078868-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078868-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2012-02-03	`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	A078868-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078868-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078868-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078868-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078868-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078868-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078868-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078868-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078868-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078868-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078868-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078868-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078868-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078868-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078868-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078868-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078868-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078868-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078868-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078868-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078868-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078868-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078868-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078868-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078868-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078868-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078868-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078868-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078868-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078868-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078868-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078868-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078868-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078868-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078868-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078868-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078868-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078868-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078868-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078868-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	AvKARE	acc8f9f6-ceb6-0505-8f11-fd7e1f105af3	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078868 application number: ANDA078868 ndc (product): 42291-810 ndc (product): 42291-812 ndc (product): 42291-811
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Apotex Corp.	3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078868 application number: ANDA078868 ndc (product): 60505-2650 ndc (product): 60505-2649 ndc (product): 60505-2648

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-810	Tizanidine Hydrochloride	Tizanidine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-810	Tizanidine Hydrochloride	Tizanidine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-810	Tizanidine Hydrochloride	Tizanidine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-811	Tizanidine Hydrochloride	Tizanidine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-811	Tizanidine Hydrochloride	Tizanidine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-811	Tizanidine Hydrochloride	Tizanidine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-812	Tizanidine Hydrochloride	Tizanidine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-812	Tizanidine Hydrochloride	Tizanidine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-812	Tizanidine Hydrochloride	Tizanidine Hydrochloride	AvKARE, Inc.	ANDA	Current
45865-954	Tizanidine Hydrochloride	Tizanidine Hydrochloride	medsource pharmaceuticals	ANDA	Current
55700-789	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-789	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Quality Care Products, LLC	ANDA	Current
60505-2648	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Apotex Corp.	ANDA	Current
60505-2648	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Apotex Corp.	ANDA	Current
60505-2648	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Apotex Corp.	ANDA	Current
60505-2649	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Apotex Corp.	ANDA	Current
60505-2649	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Apotex Corp.	ANDA	Current
60505-2649	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Apotex Corp.	ANDA	Current
60505-2650	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Apotex Corp.	ANDA	Current
60505-2650	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Apotex Corp.	ANDA	Current
60505-2650	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Apotex Corp.	ANDA	Current
71335-0317	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0317	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0317	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0317	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9192	ORIG	2012-02-10