Application 213544

Type: ANDA
Sponsor: AUROBINDO PHARMA 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
A213544-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24
A213544-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24
A213544-003	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213544-001	AB
A213544-002	AB
A213544-003	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213544-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2020-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213544-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2020-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213544-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2020-03-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A213544-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213544-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213544-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213544-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213544-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213544-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213544-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213544-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213544-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213544-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213544-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213544-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213544-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213544-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213544-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213544-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213544-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213544-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213544-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213544-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213544-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213544-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213544-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213544-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213544-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213544-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213544-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213544-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213544-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213544-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213544-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213544-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213544-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213544-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213544-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213544-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213544-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213544-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213544-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213544-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Aurobindo Pharma Limited	19cf46b5-d8dc-44cb-83d6-bacea0870dbe	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213544 application number: ANDA213544 ndc (product): 59651-315 ndc (product): 59651-314 ndc (product): 59651-316

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59651-314	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-314	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-314	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-315	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-315	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-315	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-316	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-316	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-316	Tizanidine Hydrochloride	Tizanidine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current