Application 011529

Type: NDA
Sponsor: JANSSEN R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	PARAFON FORTE DSC	CHLORZOXAZONE	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N011529-002	PARAFON FORTE DSC	CHLORZOXAZONE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1987-06-15

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011529-002	PARAFON FORTE DSC	500MG	TABLET / ORAL	RLD	1987-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011529-002	PARAFON FORTE DSC	500MG	TABLET / ORAL	RLD	1987-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`f41ea6bd6efb…`

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
268	SUPPL	2002-06-28