Application 211849

Type: ANDA
Sponsor: MAYNE PHARMA

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	500MG	No	No
003	CHLORZOXAZONE	CHLORZOXAZONE	TABLET;ORAL	750MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A211849-001	CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21
A211849-002	CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21
A211849-003	CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211849-001	AB
A211849-002	AA
A211849-003	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 · 111 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
2026-02-19 14:30 UTC	2026-02	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211849-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2020-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211849-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2020-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211849-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2020-07-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211849-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211849-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211849-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211849-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211849-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211849-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211849-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211849-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211849-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211849-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211849-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211849-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211849-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211849-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211849-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211849-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211849-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211849-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211849-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211849-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211849-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211849-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211849-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211849-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211849-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211849-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211849-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211849-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211849-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211849-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211849-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211849-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211849-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211849-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211849-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211849-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211849-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211849-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211849-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211849-001	AB	1	`8072bd15b7f6…`

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 1 · 1 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	Exact identifier application applno (ANDA): 211849 application number: ANDA211849 ndc (product): 51862-340 ndc (product): 51862-338 ndc (product): 51862-339

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51862-338	Chlorzoxazone	chlorzoxazone	Mayne Pharma	ANDA	Current
51862-338	Chlorzoxazone	chlorzoxazone	Mayne Pharma	ANDA	Current
51862-338	Chlorzoxazone	chlorzoxazone	Mayne Pharma	ANDA	Current
51862-339	Chlorzoxazone	chlorzoxazone	Mayne Pharma	ANDA	Current
51862-339	Chlorzoxazone	chlorzoxazone	Mayne Pharma	ANDA	Current
51862-339	Chlorzoxazone	chlorzoxazone	Mayne Pharma	ANDA	Current
51862-339	Chlorzoxazone	chlorzoxazone	Mayne Pharma	ANDA	Current
51862-340	Chlorzoxazone	chlorzoxazone	Mayne Pharma	ANDA	Current
51862-340	Chlorzoxazone	chlorzoxazone	Mayne Pharma	ANDA	Current
51862-340	Chlorzoxazone	chlorzoxazone	Mayne Pharma	ANDA	Current
51862-340	Chlorzoxazone	chlorzoxazone	Mayne Pharma	ANDA	Current