Application 089853

Type: ANDA
Sponsor: AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORZOXAZONE	CHLORZOXAZONE	TABLET;ORAL	500MG	No	No
002	CHLORZOXAZONE	CHLORZOXAZONE	TABLET;ORAL	375MG	No	No
003	CHLORZOXAZONE	CHLORZOXAZONE	TABLET;ORAL	750MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A089853-001	CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04
A089853-002	CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17
A089853-003	CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089853-001	AA
A089853-002	AB
A089853-003	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 · 84 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
2026-08-18 06:07:40	2026-07	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`1e350fbaab3a…`

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
2026-08-18 06:07:40	2026-07	A089853-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089853-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089853-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089853-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089853-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089853-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089853-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089853-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089853-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089853-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089853-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089853-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089853-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089853-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089853-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089853-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089853-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089853-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089853-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089853-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089853-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089853-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089853-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089853-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089853-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089853-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089853-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089853-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089853-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089853-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089853-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089853-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089853-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089853-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089853-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089853-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089853-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089853-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089853-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089853-001	AA	1	`1e350fbaab3a…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORZOXAZONE	CHLORZOXAZONE	REMEDYREPACK INC.	3f73a1d1-b3ee-4678-bc02-3258ec812127	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089853 application number: ANDA089853
CHLORZOXAZONE	CHLORZOXAZONE	Advanced Rx of Tennessee, LLC	36c1eb43-8840-8d84-e063-6394a90addca	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089853 application number: ANDA089853
CHLORZOXAZONE	CHLORZOXAZONE	Proficient Rx LP	0a8ee5fa-f393-4568-81bd-269f9a4cecd6	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089853 application number: ANDA089853 ndc (product): 71205-711
Chlorzoxazone	CHLORZOXAZONE	Advanced Rx Pharmacy of Tennessee, LLC	f8ff7293-89b6-b6ee-e053-6394a90a7d39	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089853 application number: ANDA089853
CHLORZOXAZONE	CHLORZOXAZONE	Bryant Ranch Prepack	669afcc1-d587-4dc0-8f6e-99109bcfed36	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089853 application number: ANDA089853 ndc (product): 71335-2009
CHLORZOXAZONE	CHLORZOXAZONE	Aurobindo Pharma Limited	52d3aa2c-f88f-4de7-b5ae-df8a46e94879	2023-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089853 application number: ANDA089853 ndc (product): 59651-306

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
55700-951	CHLORZOXAZONE	CHLORZOXAZONE	Quality Care Products, LLC	ANDA	Current
55700-951	CHLORZOXAZONE	CHLORZOXAZONE	Quality Care Products, LLC	ANDA	Current
59651-306	CHLORZOXAZONE	CHLORZOXAZONE	Aurobindo Pharma Limited	ANDA	Current
59651-306	CHLORZOXAZONE	CHLORZOXAZONE	Aurobindo Pharma Limited	ANDA	Current
71205-711	CHLORZOXAZONE	CHLORZOXAZONE	Proficient Rx LP	ANDA	Current
71335-2009	CHLORZOXAZONE	CHLORZOXAZONE	Bryant Ranch Prepack	ANDA	Current