Application 212898

Type: ANDA
Sponsor: TEVA PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORZOXAZONE	CHLORZOXAZONE	TABLET;ORAL	375MG	No	No
002	CHLORZOXAZONE	CHLORZOXAZONE	TABLET;ORAL	750MG	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
A212898-001	CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET / ORAL			2020-06-17
A212898-002	CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET / ORAL			2020-06-17

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 2 · 78 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	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL		2020-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL		2020-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL		2020-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL		2020-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL		2020-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL		2020-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL		2020-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL		2020-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL		2020-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL		2020-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL		2020-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL		2020-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL		2020-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL		2020-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL		2020-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL		2020-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL		2020-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL		2020-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL		2020-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL		2020-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL		2020-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL		2020-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-06-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-06-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-06-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212898-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-06-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212898-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-06-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212898-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212898-002	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212898-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212898-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212898-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212898-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212898-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212898-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212898-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212898-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212898-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212898-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212898-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212898-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212898-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212898-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212898-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212898-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212898-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212898-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212898-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212898-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212898-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A212898-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212898-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A212898-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212898-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A212898-002	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212898-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212898-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212898-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212898-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212898-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212898-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212898-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212898-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212898-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212898-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212898-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212898-002	AB	1	`a67488948f0b…`

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 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorzoxazone	CHLORZOXAZONE	Mayne Pharma Commercial LLC	5238c99e-d36e-4376-ab05-ca2535213d58	2023-07-06	Warnings, Adverse reactions	Name fallback brand name: Chlorzoxazone generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Rising Pharma Holdings, Inc.	1df6058b-7bf2-4246-9827-93fa023a5fd4	2023-06-09	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	Bryant Ranch Prepack	267a0a2a-b818-47d9-9b61-28be172de99a	2023-05-25	Warnings, Adverse reactions	Name fallback brand name: Chlorzoxazone generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Cintex Services, LLC	c95f39c4-0c11-966a-e053-2a95a90a2c18	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	A-S Medication Solutions	6c418b8f-4a1c-4611-80d5-3a3a7dbca9c8	2023-03-08	Warnings, Adverse reactions	Name fallback brand name: Chlorzoxazone generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	Proficient Rx LP	63338935-f3dd-4ef1-bb66-856a83c95f41	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Chlorzoxazone generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	Novitium Pharma LLC	69c87a85-4b6b-405b-9fa5-4c91c0f90c70	2021-10-29	Warnings, Adverse reactions	Name fallback brand name: Chlorzoxazone generic name: CHLORZOXAZONE

Reported adverse events (FAERS/openFDA)#

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