Application 040861

Type: ANDA
Sponsor: MIKART

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORZOXAZONE	CHLORZOXAZONE	TABLET;ORAL	375MG	No	Yes
002	CHLORZOXAZONE	CHLORZOXAZONE	TABLET;ORAL	750MG	No	Yes

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
A040861-001	CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01
A040861-002	CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040861-001	AB
A040861-002	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL			2010-06-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL		RS	2010-06-01	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A040861-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040861-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040861-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040861-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040861-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040861-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040861-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040861-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040861-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040861-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040861-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040861-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040861-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040861-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040861-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040861-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040861-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040861-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040861-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040861-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040861-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040861-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040861-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040861-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040861-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040861-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040861-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040861-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040861-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040861-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040861-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040861-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040861-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040861-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040861-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040861-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040861-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040861-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040861-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040861-002	AB	1	`bb7c543d1eb4…`

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13811-717	chlorzoxazone	chlorzoxazone	Trigen Laboratories, LLC	ANDA	Current
13811-717	chlorzoxazone	chlorzoxazone	Trigen Laboratories, LLC	ANDA	Current
13811-718	chlorzoxazone	chlorzoxazone	Trigen Laboratories, LLC	ANDA	Current
13811-718	chlorzoxazone	chlorzoxazone	Trigen Laboratories, LLC	ANDA	Current
46672-117	chlorzoxazone	chlorzoxazone	Mikart Inc.	ANDA	Current
46672-117	chlorzoxazone	chlorzoxazone	Mikart, LLC	ANDA	Current
46672-118	chlorzoxazone	chlorzoxazone	Mikart Inc.	ANDA	Current
46672-118	chlorzoxazone	chlorzoxazone	Mikart, LLC	ANDA	Current
55700-517	Lorzone	chlorzoxazone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
68025-046	Lorzone	chlorzoxazone	Vertical Pharmaceuticals, Inc.	ANDA	Current
68025-046	Lorzone	chlorzoxazone	Vertical Pharmaceuticals, Inc.	ANDA	Current
68025-046	Lorzone	chlorzoxazone	Vertical Pharmaceuticals, Inc.	ANDA	Current
68025-047	Lorzone	chlorzoxazone	Vertical Pharmaceuticals, Inc.	ANDA	Current
68025-047	Lorzone	chlorzoxazone	Vertical Pharmaceuticals, Inc.	ANDA	Current
68025-047	Lorzone	chlorzoxazone	Vertical Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
29967	ORIG	2010-06-08