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PARAFON FORTE DSC	CHLORZOXAZONE	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N011529-002	PARAFON FORTE DSC	CHLORZOXAZONE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1987-06-15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N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`84e616aacf4f…`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N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`caaa826d4ba7…`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UTC	2026-02	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`011fe1cb6892…`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ZIP	2025-12	N011529-002	PARAFON FORTE DSC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-06-15	`31067a03dcf5…`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 2 of 2 · 27 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	Name fallback generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Rising Pharma Holdings, Inc.	1df6058b-7bf2-4246-9827-93fa023a5fd4	2023-06-09	Warnings, Adverse reactions	Name fallback generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	Bryant Ranch Prepack	267a0a2a-b818-47d9-9b61-28be172de99a	2023-05-25	Warnings, Adverse reactions	Name fallback generic name: CHLORZOXAZONE
CHLORZOXAZONE	CHLORZOXAZONE	Cintex Services, LLC	c95f39c4-0c11-966a-e053-2a95a90a2c18	2023-05-23	Warnings, Adverse reactions	Name fallback generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	A-S Medication Solutions	6c418b8f-4a1c-4611-80d5-3a3a7dbca9c8	2023-03-08	Warnings, Adverse reactions	Name fallback generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	Proficient Rx LP	63338935-f3dd-4ef1-bb66-856a83c95f41	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: CHLORZOXAZONE
Chlorzoxazone	CHLORZOXAZONE	Novitium Pharma LLC	69c87a85-4b6b-405b-9fa5-4c91c0f90c70	2021-10-29	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