Application 208187

Type: ANDA
Sponsor: ZYDUS 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 42.

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
A208187-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2018-03-09
A208187-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2018-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208187-001	AB
A208187-002	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 · 84 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	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A208187-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208187-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208187-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208187-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208187-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208187-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208187-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208187-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208187-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208187-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208187-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208187-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208187-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208187-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208187-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208187-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208187-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208187-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208187-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208187-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208187-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208187-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208187-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208187-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208187-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208187-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208187-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208187-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208187-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208187-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208187-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208187-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208187-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208187-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208187-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208187-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208187-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208187-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208187-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208187-002	AB	1	`bb7c543d1eb4…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tizanidine	TIZANIDINE	REMEDYREPACK INC.	63b7eba3-6dea-4d89-bc42-7e965ae9795d	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	Viona Pharmaceuticals Inc	8ac00d59-bb80-4530-afe7-90e04a2130b2	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187 ndc (product): 72578-096 ndc (product): 72578-097
tizanidine	TIZANIDINE	Advanced Rx of Tennessee, LLC	30caf3b3-8c1b-268e-e063-6294a90a3c8a	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	Coupler LLC	2d9a2492-d914-f87b-e063-6394a90a38c6	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	NuCare Pharmaceuticals, Inc.	26cffb1f-21a0-017f-e063-6394a90afb1a	2025-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
Tizanidine	TIZANIDINE	Advanced Rx of Tennessee, LLC	21b7c8a8-ee07-a204-e063-6394a90a285b	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	Asclemed USA, Inc.	a9ba9023-0c3f-4c9b-ba8e-d39d23bf35d6	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	Zydus Lifesciences Limited	89105a78-badb-469e-966e-195fa3a53f0a	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187 ndc (product): 70771-1336 ndc (product): 70771-1335
tizanidine	TIZANIDINE	Advanced Rx of Tennessee, LLC	2788942d-87fa-e514-e063-6294a90a0971	2024-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	NCS HealthCare of KY, LLC dba Vangard Labs	c8278b4e-cca2-4880-8924-c8202ce084d6	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70710-1104	tizanidine	tizanidine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1104	tizanidine	tizanidine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1105	tizanidine	tizanidine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1105	tizanidine	tizanidine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1335	tizanidine	tizanidine	Cadila Healthcare Limited	ANDA	Current
70771-1335	tizanidine	tizanidine	Cadila Healthcare Limited	ANDA	Current
70771-1335	tizanidine	tizanidine	Zydus Lifesciences Limited	ANDA	Current
70771-1336	tizanidine	tizanidine	Cadila Healthcare Limited	ANDA	Current
70771-1336	tizanidine	tizanidine	Cadila Healthcare Limited	ANDA	Current
70771-1336	tizanidine	tizanidine	Zydus Lifesciences Limited	ANDA	Current
72578-096	tizanidine	tizanidine	Viona Pharmaceuticals Inc	ANDA	Current
72578-097	tizanidine	tizanidine	Viona Pharmaceuticals Inc	ANDA	Current