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 42.

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 · 84 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
2026-08-18 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…`
2022-03-09 01:35 UTC	2022-03	A040861-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	RS	2010-06-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040861-002	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	RS	2010-06-01	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	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…`
2021-12-28 21:50 UTC	2021-12	A040861-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040861-002	AB	1	`782e0a99824c…`

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 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORZOXAZONE	CHLORZOXAZONE	Bryant Ranch Prepack	6c77ca6b-fda6-43ab-8179-3e0bde6aa65f	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	REMEDYREPACK INC.	3f73a1d1-b3ee-4678-bc02-3258ec812127	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	PD-Rx Pharmaceuticals, Inc.	8650d342-92df-48d7-9f3d-cdd6f6f4c0e7	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Chlorzoxazone generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Happy Robin, LLC	3f90c7bc-118f-4371-e063-6394a90a279a	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
chlorzoxazone	CHLORZOXAZONE	Solubiomix	c3d40a90-6df8-4b44-bc61-d7655c52bacb	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: chlorzoxazone generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	Rising Pharma Holdings, Inc.	e0d10d67-9716-450b-b8a9-4e157008864e	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Chlorzoxazone generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Advanced Rx of Tennessee, LLC	36c1eb43-8840-8d84-e063-6394a90addca	2025-05-29	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Advanced Rx of Tennessee, LLC	30c9b3ce-198d-0c16-e063-6394a90a857d	2025-03-20	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	Lifsa Drugs LLC	0f222059-1ece-44f3-ae7f-d277e5bcaba4	2025-03-16	Warnings, Adverse reactions	Name fallback brand name: Chlorzoxazone generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Camber Pharmaceuticals, Inc.	e9bb9ebf-fceb-4da8-950a-c4b1fd5a84f1	2025-03-16	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Proficient Rx LP	0a8ee5fa-f393-4568-81bd-269f9a4cecd6	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	A-S Medication Solutions	d0210638-b828-4c05-9669-fd61ef987317	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	Advanced Rx Pharmacy of Tennessee, LLC	f8ff7293-89b6-b6ee-e053-6394a90a7d39	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Chlorzoxazone generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	Endo USA, Inc.	7c5a835d-3754-4c25-a0e2-335b8eceb2d2	2024-12-03	Warnings, Adverse reactions	Name fallback brand name: Chlorzoxazone generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	Bryant Ranch Prepack	5e6889c9-a091-4622-0a00-ad0fc1830f78	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Chlorzoxazone generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Bryant Ranch Prepack	d7f09907-83b2-46cf-947d-fa38dcf88685	2024-09-09	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	Actavis Pharma, Inc.	2f05e8e2-616f-475b-ac9f-c42e1a5dbe81	2024-08-25	Warnings, Adverse reactions	Name fallback brand name: Chlorzoxazone generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Bryant Ranch Prepack	669afcc1-d587-4dc0-8f6e-99109bcfed36	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Cintex Services, LLC	13a1aa33-6971-da5a-e063-6394a90a9e12	2024-03-21	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Aurobindo Pharma Limited	52d3aa2c-f88f-4de7-b5ae-df8a46e94879	2023-09-05	Warnings, Adverse reactions	Name fallback brand name: CHLORZOXAZONE generic name: CHLORZOXAZONE

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