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 43.

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 · 86 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	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A076286-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076286-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076286-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076286-002	AB	1	`caaa826d4ba7…`
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…`

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 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine	TIZANIDINE	Redpharm Drug	59d83e3a-5e44-d8d0-e063-6294a90aa65a	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	9bcc7f09-d2b5-4602-aaf3-5410b55ce275	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
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
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
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	7bbc81e5-ad3e-496b-908f-e6f500f6ad7e	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286 ndc (product): 70518-3112
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
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
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 ndc (product): 80425-0023
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
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
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 ndc (product): 76420-228 ndc (product): 76420-229
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
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
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

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 2 of 2 · 96 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-0133	Tizanidine	Tizanidine	REMEDYREPACK INC.	ANDA	Current
70518-0133	Tizanidine	Tizanidine	REMEDYREPACK INC.	ANDA	Current
70518-0573	Tizanidine	Tizanidine	REMEDYREPACK INC.	ANDA	Current
70518-0573	Tizanidine	Tizanidine	REMEDYREPACK INC.	ANDA	Current
70518-0573	Tizanidine	Tizanidine	REMEDYREPACK INC.	ANDA	Current
70518-0573	Tizanidine	Tizanidine	REMEDYREPACK INC.	ANDA	Current
70518-0573	Tizanidine	Tizanidine	REMEDYREPACK INC.	ANDA	Current
70518-0573	Tizanidine	Tizanidine	REMEDYREPACK INC.	ANDA	Current
70518-3112	Tizanidine	Tizanidine	REMEDYREPACK INC.	ANDA	Current
70934-811	Tizanidine	Tizanidine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-811	Tizanidine	Tizanidine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
76420-228	Tizanidine	Tizanidine	Asclemed USA, Inc.	ANDA	Current
76420-229	Tizanidine	Tizanidine	Asclemed USA, Inc.	ANDA	Current
80425-0023	Zanaflex	Tizanidine HCl 4mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0023	Tizanidine HCL	Tizanidine HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0023	Tizanidine HCL	Tizanidine HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current