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 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
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A089853-001	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A089853-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A089853-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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