Application 089859

Type: ANDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORZOXAZONE	CHLORZOXAZONE	TABLET;ORAL	500MG	No	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A089859-001	CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089859-001	AA

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 2 · 42 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	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL		RS	1988-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL		RS	1988-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089859-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	RS	1988-05-04	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A089859-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089859-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089859-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089859-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089859-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089859-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089859-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089859-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089859-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089859-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089859-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089859-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089859-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089859-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089859-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089859-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089859-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089859-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089859-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089859-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089859-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089859-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089859-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089859-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089859-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089859-001	AA	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089859-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089859-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089859-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089859-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089859-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089859-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089859-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089859-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089859-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089859-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089859-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089859-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089859-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A089859-001	AA	1	`a50c72e98297…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorzoxazone	CHLORZOXAZONE	PD-Rx Pharmaceuticals, Inc.	8650d342-92df-48d7-9f3d-cdd6f6f4c0e7	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089859 application number: ANDA089859 ndc (product): 55289-633
Chlorzoxazone	CHLORZOXAZONE	Bryant Ranch Prepack	5e6889c9-a091-4622-0a00-ad0fc1830f78	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089859 application number: ANDA089859 ndc (product): 63629-1586
Chlorzoxazone	CHLORZOXAZONE	Actavis Pharma, Inc.	2f05e8e2-616f-475b-ac9f-c42e1a5dbe81	2024-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089859 application number: ANDA089859 ndc (product): 0591-2520
Chlorzoxazone	CHLORZOXAZONE	A-S Medication Solutions	6c418b8f-4a1c-4611-80d5-3a3a7dbca9c8	2023-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089859 application number: ANDA089859 ndc (product): 50090-0315
Chlorzoxazone	CHLORZOXAZONE	Proficient Rx LP	63338935-f3dd-4ef1-bb66-856a83c95f41	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089859 application number: ANDA089859 ndc (product): 63187-317

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2520	Chlorzoxazone	Chlorzoxazone	Actavis Pharma, Inc.	ANDA	Current
0591-2520	Chlorzoxazone	Chlorzoxazone	Actavis Pharma, Inc.	ANDA	Current
33261-021	Chlorzoxazone	Chlorzoxazone	Aidarex Pharmaceuticals LLC	ANDA	Current
42254-076	Chlorzoxazone	Chlorzoxazone	Rebel Distributors Corp	ANDA	Current
45865-434	Chlorzoxazone	Chlorzoxazone	Medsource Pharmaceuticals	ANDA	Current
49999-044	Chlorzoxazone	Chlorzoxazone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-044	Chlorzoxazone	Chlorzoxazone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-044	Chlorzoxazone	Chlorzoxazone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0315	Chlorzoxazone	Chlorzoxazone	A-S Medication Solutions	ANDA	Current
50090-0315	Chlorzoxazone	Chlorzoxazone	A-S Medication Solutions	ANDA	Current
50090-0316	Chlorzoxazone	Chlorzoxazone	A-S Medication Solutions	ANDA	Current
50090-0316	Chlorzoxazone	Chlorzoxazone	A-S Medication Solutions	ANDA	Current
53002-5760	Chlorzoxazone	Chlorzoxazone	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-5760	Chlorzoxazone	Chlorzoxazone	RPK Pharmaceuticals, Inc.	ANDA	Current
55289-633	Chlorzoxazone	Chlorzoxazone	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-633	Chlorzoxazone	Chlorzoxazone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-633	Chlorzoxazone	Chlorzoxazone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-633	Chlorzoxazone	Chlorzoxazone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-633	Chlorzoxazone	Chlorzoxazone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-633	Chlorzoxazone	Chlorzoxazone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60760-479	Chlorzoxazone	Chlorzoxazone	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-479	Chlorzoxazone	Chlorzoxazone	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-478	CHLORZOXAZONE	CHLORZOXAZONE	DIRECT RX	ANDA	Current
61919-478	CHLORZOXAZONE	CHLORZOXAZONE	DIRECT RX	ANDA	Current
61919-478	CHLORZOXAZONE	CHLORZOXAZONE	DIRECT RX	ANDA	Current
63187-317	Chlorzoxazone	Chlorzoxazone	Proficient Rx LP	ANDA	Current
63187-317	Chlorzoxazone	Chlorzoxazone	Proficient Rx LP	ANDA	Current
63187-317	Chlorzoxazone	Chlorzoxazone	Proficient Rx LP	ANDA	Current
63629-1586	Chlorzoxazone	Chlorzoxazone	Bryant Ranch Prepack	ANDA	Current
66267-055	Chlorzoxazone	Chlorzoxazone	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-055	Chlorzoxazone	Chlorzoxazone	NuCare Pharmaceuticals, Inc.	ANDA	Current
66336-663	Chlorzoxazone	Chlorzoxazone	Dispensing Solutions, Inc.	ANDA	Current
70518-0496	Chlorzoxazone	Chlorzoxazone	REMEDYREPACK INC.	ANDA	Current
70518-0496	Chlorzoxazone	Chlorzoxazone	REMEDYREPACK INC.	ANDA	Current
70518-0496	Chlorzoxazone	Chlorzoxazone	REMEDYREPACK INC.	ANDA	Current
70518-0496	Chlorzoxazone	Chlorzoxazone	REMEDYREPACK INC.	ANDA	Current
70518-0496	Chlorzoxazone	Chlorzoxazone	REMEDYREPACK INC.	ANDA	Current
70518-0496	Chlorzoxazone	Chlorzoxazone	REMEDYREPACK INC.	ANDA	Current
70518-2053	Chlorzoxazone	Chlorzoxazone	REMEDYREPACK INC.	ANDA	Current
70518-2053	Chlorzoxazone	Chlorzoxazone	REMEDYREPACK INC.	ANDA	Current
70518-2053	Chlorzoxazone	Chlorzoxazone	REMEDYREPACK INC.	ANDA	Current
70518-2053	Chlorzoxazone	Chlorzoxazone	REMEDYREPACK INC.	ANDA	Current