Application 207199

Type: ANDA
Sponsor: PAR PHARM INC

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	Approval date
A207199-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14
A207199-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14
A207199-003	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207199-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	2017-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207199-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2017-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207199-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2017-03-14	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A207199-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207199-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207199-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207199-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207199-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207199-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207199-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207199-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207199-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207199-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207199-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207199-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207199-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207199-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207199-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207199-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207199-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207199-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207199-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207199-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207199-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207199-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207199-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207199-003	AB	1	`ea99ee380514…`

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 2 of 2 · 29 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	Name fallback brand name: Tizanidine Hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	99cc8f5f-b947-4ddc-99b6-1e4cef09b717	2025-01-10	Warnings, Adverse reactions	Name fallback brand name: TIZANIDINE HYDROCHLORIDE generic name: TIZANIDINE HYDROCHLORIDE
Tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Cadila Pharmaceuticals Limited	f2f4e117-0318-4bbd-aaa7-fab803714f21	2024-12-23	Warnings, Adverse reactions	Name fallback brand name: Tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ee3e9813-a738-46d1-9c05-c931aee1495c	2024-12-17	Warnings, Adverse reactions	Name fallback brand name: Tizanidine Hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Quality Care Products LLC	87f8a776-e8ae-4aed-a221-98ca72a2bedf	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: Tizanidine Hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	26f8f233-5dc2-0013-e063-6394a90ab0f5	2024-10-29	Warnings, Adverse reactions	Name fallback brand name: TIZANIDINE HYDROCHLORIDE generic name: TIZANIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	Bryant Ranch Prepack	ff7a82ea-c03c-44f6-9b15-468cb8d15a9c	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: TIZANIDINE HYDROCHLORIDE generic name: TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	cb8b01b3-bcec-4762-9d67-0db018ef6b22	2023-03-10	Warnings, Adverse reactions	Name fallback brand name: tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	29750221-497e-4747-a9b8-12a0c2236eae	2023-01-30	Warnings, Adverse reactions	Name fallback brand name: Tizanidine Hydrochloride generic name: TIZANIDINE HYDROCHLORIDE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-611	tizanidine hydrochloride	tizanidine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-611	tizanidine hydrochloride	tizanidine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-719	tizanidine hydrochloride	tizanidine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-719	tizanidine hydrochloride	tizanidine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-765	tizanidine hydrochloride	tizanidine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-765	tizanidine hydrochloride	tizanidine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current