Application 213798

Type: ANDA
Sponsor: RUBICON

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
004	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 8MG BASE	No	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213798-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27
A213798-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27
A213798-003	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27
A213798-004	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 8MG BASE	CAPSULE / ORAL		RS	2025-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213798-001	AB
A213798-002	AB
A213798-003	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 3 · 114 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
2026-02-19 14:30 UTC	2026-02	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213798-004	TIZANIDINE HYDROCHLORIDE	EQ 8MG BASE	CAPSULE / ORAL		RS	2025-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-004	TIZANIDINE HYDROCHLORIDE	EQ 8MG BASE	CAPSULE / ORAL		RS	2025-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213798-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213798-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213798-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213798-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213798-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213798-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213798-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213798-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213798-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213798-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213798-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213798-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213798-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213798-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213798-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213798-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213798-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213798-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213798-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213798-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213798-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213798-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213798-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213798-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213798-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213798-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213798-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213798-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213798-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213798-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213798-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213798-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213798-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213798-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213798-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213798-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213798-001	AB	1	`8072bd15b7f6…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine	TIZANIDINE	Direct_Rx	5460dbf8-b30d-db94-e063-6394a90a5553	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Trifluent Pharma, LLC	4a2cf456-58c5-c26d-e063-6294a90a0b24	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ebccdb33-2b3c-4071-9765-8d95bcbc9b5f	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2c2bdad9-74a5-8508-e063-6294a90aac7f	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Bryant Ranch Prepack	9d127a0b-b182-4c8a-91a3-311cc936fd4c	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
Zanaflex	TIZANIDINE HYDROCHLORIDE	Trifluent Pharma, LLC	9833a1b8-f530-4a06-bc77-7d11b6e94c65	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Advagen Pharma Limited	7f39499a-98cf-4d13-9b07-ccb5c22e43c8	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798 ndc (product): 72888-002 ndc (product): 72888-001 ndc (product): 72888-003
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d7d5dce0-f8a2-404d-9e87-e2235f5d3268	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e19f83b8-8c59-415c-a744-7473d46ab0ca	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e94aa8b1-74ed-46b7-94c5-53d5d5630be6	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Bryant Ranch Prepack	58c10b87-004e-4d2d-b5c1-b353c2cd071f	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72888-001	tizanidine hydrochloride	tizanidine hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-001	tizanidine hydrochloride	tizanidine hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-002	tizanidine hydrochloride	tizanidine hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-002	tizanidine hydrochloride	tizanidine hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-003	tizanidine hydrochloride	tizanidine hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-003	tizanidine hydrochloride	tizanidine hydrochloride	Advagen Pharma Limited	ANDA	Current