Application 076286

Type: ANDA
Sponsor: DR REDDYS LABS 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
A076286-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2002-07-03
A076286-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2002-07-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076286-001	AB
A076286-002	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.

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	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A076286-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076286-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076286-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076286-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076286-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076286-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076286-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076286-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076286-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076286-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076286-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076286-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076286-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076286-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076286-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076286-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076286-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076286-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076286-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076286-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076286-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076286-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076286-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076286-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076286-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076286-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076286-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076286-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076286-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076286-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076286-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076286-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076286-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076286-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076286-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076286-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076286-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076286-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076286-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076286-002	AB	1	`782e0a99824c…`

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 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine	TIZANIDINE	HAWAII REPACK, INC.	45de30ce-959f-4e2e-a974-6f90568139c9	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	59084f59-9a9b-49f0-a9f4-27f3eab9a228	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286 ndc (product): 70518-0133
Tizanidine	TIZANIDINE	Redpharm Drug	54ade0c7-4bf0-54d4-e063-6294a90a8b17	2026-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	St. Mary's Medical Park Pharmacy	c6b4486f-e847-64ee-e053-2995a90a855a	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286 ndc (product): 60760-505
Tizanidine	TIZANIDINE	St. Mary's Medical Park Pharmacy	cfd52c0c-a7c2-e23d-e053-2a95a90abbd1	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286 ndc (product): 60760-694
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	9bcc7f09-d2b5-4602-aaf3-5410b55ce275	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	7bbc81e5-ad3e-496b-908f-e6f500f6ad7e	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Direct_rx	29a275f9-de6b-ee63-e063-6294a90aba28	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	AvPAK	b694225c-1fa9-4726-89a6-fd3f87084248	2026-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286 ndc (product): 50268-759 ndc (product): 50268-760
Tizanidine	TIZANIDINE	PD-Rx Pharmaceuticals, Inc.	ac897a5a-677b-4a6e-abb1-b810470200fc	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286 ndc (product): 43063-455
Tizanidine	TIZANIDINE	Northwind Health Company, LLC	da31fbeb-3781-5e75-e053-2a95a90adb73	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine HCl	TIZANIDINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	afc90292-c6bf-2d96-e053-2995a90abf00	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Preferred Pharmaceuticals Inc.	3c993e3c-ee52-45a7-be39-60eaac7a1092	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286 ndc (product): 68788-7991
Tizanidine	TIZANIDINE	Preferred Pharmaceuticals, Inc.	32c3be66-5398-425c-ac65-e57ba819bb43	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286 ndc (product): 68788-7781
Tizanidine	TIZANIDINE	Asclemed USA, Inc.	24d8b33f-d1fb-4b4a-afbe-e2e7134dce29	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	PHOENIX RX LLC	3a7b9b9a-9bf9-0b37-e063-6294a90a1c39	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	American Health Packaging	3670f9e3-988d-48e6-9df0-d403d699e08a	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286 ndc (product): 68084-645 ndc (product): 68084-775
Tizanidine	TIZANIDINE	A-S Medication Solutions	180985f0-3fbd-4868-a826-b84101618a03	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286 ndc (product): 50090-0811 ndc (product): 50090-0840
Tizanidine	TIZANIDINE	NuCare Pharmaceuticals,Inc.	fe2f5064-0b7c-d03d-e053-6294a90a9604	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Proficient Rx LP	c2353d09-3cb4-486e-8ae7-29339c1ba76b	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286 ndc (product): 63187-009

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 96 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-5574	Tizanidine	Tizanidine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-6564	Tizanidine	Tizanidine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10544-890	Tizanidine	Tizanidine	Blenheim Pharmacal, Inc.	ANDA	Current
16714-171	Tizanidine	Tizanidine	NorthStar Rx LLC	ANDA	Current
16714-172	Tizanidine	Tizanidine	NorthStar Rx LLC	ANDA	Current
33261-103	Tizanidine	Tizanidine	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-104	Tizanidine	Tizanidine	Aidarex Pharmaceuticals LLC	ANDA	Current
35356-662	Tizanidine	Tizanidine	Quality Care Products, LLC	ANDA	Current
35356-662	Tizanidine	Tizanidine	Quality Care Products, LLC	ANDA	Current
35356-662	Tizanidine	Tizanidine	Quality Care Products, LLC	ANDA	Current
43063-455	Tizanidine	Tizanidine	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-455	Tizanidine	Tizanidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-455	Tizanidine	Tizanidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-455	Tizanidine	Tizanidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-455	Tizanidine	Tizanidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-455	Tizanidine	Tizanidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-455	Tizanidine	Tizanidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-455	Tizanidine	Tizanidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45865-348	Tizanidine	Tizanidine	Medsource Pharmaceuticals	ANDA	Current
45865-386	Tizanidine	Tizanidine	Medsource Pharmaceuticals	ANDA	Current
49999-347	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-347	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-347	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-347	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0811	Tizanidine	Tizanidine	A-S Medication Solutions	ANDA	Current
50090-0811	Tizanidine	Tizanidine	A-S Medication Solutions	ANDA	Current
50090-0811	Tizanidine	Tizanidine	A-S Medication Solutions	ANDA	Current
50090-0811	Tizanidine	Tizanidine	A-S Medication Solutions	ANDA	Current
50090-0811	Tizanidine	Tizanidine	A-S Medication Solutions	ANDA	Current
50090-0840	Tizanidine	Tizanidine	A-S Medication Solutions	ANDA	Current
50090-0840	Tizanidine	Tizanidine	A-S Medication Solutions	ANDA	Current
50090-0840	Tizanidine	Tizanidine	A-S Medication Solutions	ANDA	Current
50268-759	Tizanidine	Tizanidine	AvPAK	ANDA	Current
50268-759	Tizanidine	Tizanidine	AvPAK	ANDA	Current
50268-760	Tizanidine	Tizanidine	AvPAK	ANDA	Current
50268-760	Tizanidine	Tizanidine	AvPAK	ANDA	Current
50436-1180	Tizanidine	Tizanidine	Unit Dose Services	ANDA	Current
50436-6755	Tizanidine	Tizanidine	Unit Dose Services	ANDA	Current
50436-6756	Tizanidine	Tizanidine	Unit Dose Services	ANDA	Current
52959-689	Tizanidine	Tizanidine	H.J. Harkins Company, Inc.	ANDA	Current
52959-691	Tizanidine	Tizanidine	H.J. Harkins Company, Inc.	ANDA	Current
55111-179	Tizanidine	Tizanidine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-179	Tizanidine	Tizanidine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-180	Tizanidine	Tizanidine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-180	Tizanidine	Tizanidine	Dr. Reddy's Laboratories Limited	ANDA	Current
60760-505	Tizanidine	Tizanidine	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-505	Tizanidine	Tizanidine	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-505	Tizanidine	Tizanidine	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-505	Tizanidine	Tizanidine	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-694	Tizanidine	Tizanidine	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-694	Tizanidine	Tizanidine	St Mary's Medical Park Pharmacy	ANDA	Current
63187-009	Tizanidine	Tizanidine	Proficient Rx LP	ANDA	Current
63187-009	Tizanidine	Tizanidine	Proficient Rx LP	ANDA	Current
63187-009	Tizanidine	Tizanidine	Proficient Rx LP	ANDA	Current
63629-1673	Tizanidine	Tizanidine	Bryant Ranch Prepack	ANDA	Current
63629-1673	Tizanidine	Tizanidine	Bryant Ranch Prepack	ANDA	Current
63629-3209	Tizanidine	Tizanidine	Bryant Ranch Prepack	ANDA	Current
63629-3209	Tizanidine	Tizanidine	Bryant Ranch Prepack	ANDA	Current
63874-087	Tizanidine	Tizanidine	Altura Pharmaceuticals, Inc.	ANDA	Current
66336-843	Tizanidine	Tizanidine	Dispensing Solutions, Inc.	ANDA	Current
67296-1417	Tizanidine	Tizanidine	RedPharm Drug, Inc.	ANDA	Current
68071-5268	Tizanidine	Tizanidine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5268	Tizanidine	Tizanidine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5268	Tizanidine	Tizanidine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5268	Tizanidine	Tizanidine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-645	Tizanidine	Tizanidine	American Health Packaging	ANDA	Current
68084-645	Tizanidine	Tizanidine	American Health Packaging	ANDA	Current
68084-645	Tizanidine	Tizanidine	American Health Packaging	ANDA	Current
68084-775	Tizanidine	Tizanidine	American Health Packaging	ANDA	Current
68084-775	Tizanidine	Tizanidine	American Health Packaging	ANDA	Current
68084-775	Tizanidine	Tizanidine	American Health Packaging	ANDA	Current
68788-7781	Tizanidine	Tizanidine	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7781	Tizanidine	Tizanidine	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7781	Tizanidine	Tizanidine	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7991	Tizanidine	Tizanidine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7991	Tizanidine	Tizanidine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9091	Tizanidine	Tizanidine	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9092	Tizanidine	Tizanidine	Preferred Pharmaceuticals, Inc	ANDA	Current
70518-0133	Tizanidine	Tizanidine	REMEDYREPACK INC.	ANDA	Current
70518-0133	Tizanidine	Tizanidine	REMEDYREPACK INC.	ANDA	Current