Application 076281

Type: ANDA
Sponsor: OXFORD PHARMS

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
A076281-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2003-10-20
A076281-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2003-10-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076281-001	AB
A076281-002	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.

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
2026-08-01 22:54:32	2026-06	A076281-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2003-10-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076281-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2003-10-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A076281-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076281-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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