Application 212196

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A212196-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27
A212196-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27
A212196-003	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212196-001	AB
A212196-002	AB
A212196-003	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	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`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	A212196-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212196-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212196-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212196-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212196-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212196-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212196-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212196-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212196-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212196-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212196-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212196-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212196-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212196-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212196-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212196-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212196-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212196-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212196-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212196-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212196-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212196-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212196-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212196-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212196-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212196-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212196-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212196-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212196-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212196-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212196-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212196-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212196-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212196-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212196-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212196-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212196-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212196-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212196-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212196-001	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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	649f1f76-da33-4bdf-a38d-5ae3a9cb7987	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196 ndc (product): 71335-2077
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	70b1a815-8549-4602-af35-fdbedf5fad51	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	4fd5b1b8-ec86-42c2-9065-aee581f1bdd6	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	226b506f-6f85-48e8-b8e5-86442d74d951	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	31b40276-099b-482c-a13c-8fbbf1ebc50a	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	04febb37-00d6-4279-8c5f-171950278c8f	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	3288d98d-aa49-4a36-a6d9-703645d8bcd7	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3f569c5a-ec9d-4356-ac04-c17714ff68d1	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Ascend Laboratories, LLC	d7c97b79-da59-4e86-a01b-f91046d04f74	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196 ndc (product): 67877-611 ndc (product): 67877-610 ndc (product): 67877-612
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Asclemed USA, Inc.	07b8db58-d037-477e-a62f-025e8a5afcb4	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidine HCL	TIZANIDINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	c46c7aa3-69db-82dc-e053-2995a90ac251	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196 ndc (product): 80425-0144
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	00fcd792-18a4-45d9-9c6e-0634b54b152a	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196 ndc (product): 63629-8872
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	a4233306-2954-496f-9686-22c48041710d	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196 ndc (product): 63629-8873
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	30df9966-5076-449f-867b-28cb9b835693	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196 ndc (product): 63629-8871
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Asclemed USA, Inc.	1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9c	2022-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196 ndc (product): 76420-231

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-8871	Tizanidne hydrochloride	Tizanidne Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8871	Tizanidne hydrochloride	Tizanidne Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8871	Tizanidne hydrochloride	Tizanidne Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8872	Tizanidne hydrochloride	Tizanidne Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8872	Tizanidne hydrochloride	Tizanidne Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8872	Tizanidne hydrochloride	Tizanidne Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8873	Tizanidne hydrochloride	Tizanidne Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8873	Tizanidne hydrochloride	Tizanidne Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8873	Tizanidne hydrochloride	Tizanidne Hydrochloride	Bryant Ranch Prepack	ANDA	Current
67296-1793	Tizanidne hydrochloride	Tizanidne Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1793	Tizanidne hydrochloride	Tizanidne Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67877-610	Tizanidne hydrochloride	Tizanidne Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-610	Tizanidne hydrochloride	Tizanidne Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-610	Tizanidne hydrochloride	Tizanidne Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-611	Tizanidne hydrochloride	Tizanidne Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-611	Tizanidne hydrochloride	Tizanidne Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-611	Tizanidne hydrochloride	Tizanidne Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-612	Tizanidne hydrochloride	Tizanidne Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-612	Tizanidne hydrochloride	Tizanidne Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-612	Tizanidne hydrochloride	Tizanidne Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
68788-7962	Tizanidne hydrochloride	Tizanidne Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7962	Tizanidne hydrochloride	Tizanidne Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-2077	Tizanidne hydrochloride	Tizanidne Hydrochloride	Bryant Ranch Prepack	ANDA	Current
76420-231	Tizanidne hydrochloride	Tizanidne Hydrochloride	Asclemed USA, Inc.	ANDA	Current
80425-0144	Zanaflex	Tizanidine 4mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0144	Tizanidine HCL	Tizanidine HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0144	Tizanidine HCL	Tizanidine HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0144	Tizanidine HCL	Tizanidine HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current