Application 076280

Type: ANDA
Sponsor: CASI PHARMS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076280-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL			2002-11-26
A076280-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL			2002-06-27

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-11-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-11-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-06-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076280-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076280-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076280-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076280-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076280-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076280-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076280-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076280-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076280-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076280-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076280-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076280-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076280-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076280-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076280-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076280-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076280-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076280-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076280-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076280-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076280-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076280-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076280-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076280-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076280-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076280-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076280-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076280-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076280-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076280-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076280-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076280-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076280-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076280-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076280-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076280-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076280-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076280-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076280-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076280-002	AB	1	`3f0d92c62455…`

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Kanchan Healthcare Inc	22ea819a-2aaa-44e0-a350-258541b11220	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	047c67cd-7a63-49c9-b100-71651d3537ba	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: TIZANIDINE HYDROCHLORIDE generic name: TIZANIDINE HYDROCHLORIDE
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Trifluent Pharma, LLC	4a2cf456-58c5-c26d-e063-6294a90a0b24	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: Tizanidine Hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ebccdb33-2b3c-4071-9765-8d95bcbc9b5f	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
Zanaflex	TIZANIDINE HYDROCHLORIDE	Legacy Pharma USA, Inc.	60c27d35-7349-4fc6-86ad-70fffdbe3e08	2026-01-02	Warnings, Adverse reactions	Name fallback generic name: TIZANIDINE HYDROCHLORIDE
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Asclemed USA, Inc.	07b8db58-d037-477e-a62f-025e8a5afcb4	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Tizanidine Hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Zydus Lifesciences Limited	5f4889d1-1387-4c90-9b76-00beda3c1683	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	146c853c-99a8-4bf3-b1e3-be6876abe6ff	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2c2bdad9-74a5-8508-e063-6294a90aac7f	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	AvKARE	acc8f9f6-ceb6-0505-8f11-fd7e1f105af3	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Tizanidine Hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Bryant Ranch Prepack	9d127a0b-b182-4c8a-91a3-311cc936fd4c	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
Ontralfy	TIZANIDINE HYDROCHLORIDE	Rosemont Pharmaceuticals, LLC	7b88c338-c0b7-4c08-bef6-a4ffc2f25df7	2025-10-25	Warnings, Adverse reactions	Name fallback generic name: TIZANIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ae9b6808-632f-4204-8581-bf146dcab69f	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: TIZANIDINE HYDROCHLORIDE generic name: TIZANIDINE HYDROCHLORIDE
Zanaflex	TIZANIDINE HYDROCHLORIDE	Trifluent Pharma, LLC	9833a1b8-f530-4a06-bc77-7d11b6e94c65	2025-09-30	Warnings, Adverse reactions	Name fallback generic name: TIZANIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	4009c6cb-c183-2165-e063-6294a90aed78	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: TIZANIDINE HYDROCHLORIDE generic name: TIZANIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	6439a7ef-1b22-4fa1-9be3-eedd3cd24191	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: TIZANIDINE HYDROCHLORIDE generic name: TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Advagen Pharma Limited	7f39499a-98cf-4d13-9b07-ccb5c22e43c8	2025-09-25	Warnings, Adverse reactions	Name fallback brand name: tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Apotex Corp.	3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe	2025-08-19	Warnings, Adverse reactions	Name fallback brand name: Tizanidine Hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d7d5dce0-f8a2-404d-9e87-e2235f5d3268	2025-08-05	Warnings, Adverse reactions	Name fallback brand name: tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e19f83b8-8c59-415c-a744-7473d46ab0ca	2025-05-16	Warnings, Adverse reactions	Name fallback brand name: tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0034	tizanidine hydrochloride	tizanidine hydrochloride	Eon Labs, Inc.	ANDA	Current
0185-4400	tizanidine hydrochloride	tizanidine hydrochloride	Eon Labs, Inc.	ANDA	Current
43063-237	Comfort Pac with Tizanidine	Tizanidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-784	tizanidine hydrochloride	tizanidine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-784	tizanidine hydrochloride	tizanidine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-784	tizanidine hydrochloride	tizanidine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-784	tizanidine hydrochloride	tizanidine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-784	tizanidine hydrochloride	tizanidine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-784	tizanidine hydrochloride	tizanidine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
63629-6537	tizanidine hydrochloride	tizanidine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-6537	tizanidine hydrochloride	tizanidine hydrochloride	Bryant Ranch Prepack	ANDA	Current
68788-6431	tizanidine hydrochloride	tizanidine hydrochloride	Preferred Pharmaceuticals	ANDA	Current
71610-114	tizanidine hydrochloride	tizanidine hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current