Application 208622

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	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 43.

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
A208622-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03
A208622-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03
A208622-003	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208622-001	AB
A208622-002	AB
A208622-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208622-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2017-03-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208622-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2017-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208622-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2017-03-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208622-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208622-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208622-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208622-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208622-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208622-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208622-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208622-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208622-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208622-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208622-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208622-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208622-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208622-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208622-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208622-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208622-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208622-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208622-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208622-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208622-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208622-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208622-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208622-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208622-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208622-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208622-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208622-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208622-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208622-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208622-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208622-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208622-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208622-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208622-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208622-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208622-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208622-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208622-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208622-001	AB	1	`301d65b070ca…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Zydus Lifesciences Limited	5f4889d1-1387-4c90-9b76-00beda3c1683	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208622 application number: ANDA208622 ndc (product): 70771-1069 ndc (product): 70771-1068 ndc (product): 70771-1067
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	146c853c-99a8-4bf3-b1e3-be6876abe6ff	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208622 application number: ANDA208622 ndc (product): 70710-1113 ndc (product): 70710-1112 ndc (product): 70710-1111

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70710-1111	tizanidine hydrochloride	tizanidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1111	tizanidine hydrochloride	tizanidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1111	tizanidine hydrochloride	tizanidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1112	tizanidine hydrochloride	tizanidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1112	tizanidine hydrochloride	tizanidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1112	tizanidine hydrochloride	tizanidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1113	tizanidine hydrochloride	tizanidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1113	tizanidine hydrochloride	tizanidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1113	tizanidine hydrochloride	tizanidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1067	tizanidine hydrochloride	tizanidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1067	tizanidine hydrochloride	tizanidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1067	tizanidine hydrochloride	tizanidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1068	tizanidine hydrochloride	tizanidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1068	tizanidine hydrochloride	tizanidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1068	tizanidine hydrochloride	tizanidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1069	tizanidine hydrochloride	tizanidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1069	tizanidine hydrochloride	tizanidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1069	tizanidine hydrochloride	tizanidine hydrochloride	Cadila Healthcare Limited	ANDA	Current