FDA Orange Book · active-ingredient family
Chlorzoxazone
Chlorzoxazone is approved as 2 brand and 36 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PARAFON FORTE DSC · NDA 011529
2
Brand (NDA)
36
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PARAFON FORTE DSCRLD | JANSSEN R AND D | NDA 011529 | — | Jun 15, 1987 | |
| PARAFLEXRLD | ORTHO MCNEIL PHARM | NDA 011300 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (36)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHLORZOXAZONE | SENORES PHARMS | ANDA 210961 | AA | Jan 22, 2024 | |
| CHLORZOXAZONE×3 | AUROBINDO PHARMA LTD | ANDA 089853 | AB | Aug 17, 2023 | |
| CHLORZOXAZONE | RISING | ANDA 216925 | AA | Aug 09, 2023 | |
| CHLORZOXAZONE | ACME LABS | ANDA 214365 | — | Apr 27, 2023 | |
| CHLORZOXAZONE | COREPHARMA | ANDA 214702 | AA | Apr 10, 2023 | |
| CHLORZOXAZONE×2 | SOMERSET THERAPS LLC | ANDA 212047 | AB | Jan 27, 2023 | |
| CHLORZOXAZONE | AJENAT PHARMS | ANDA 215540 | AA | Jan 24, 2023 | |
| CHLORZOXAZONE×3 | COREPHARMA | ANDA 214941 | AB | Oct 20, 2022 | |
| CHLORZOXAZONE×3 | RISING | ANDA 213126 | AB | Apr 05, 2022 | |
| CHLORZOXAZONE | SENORES PHARMS | ANDA 215158 | AA | Jul 29, 2021 | |
| CHLORZOXAZONE×2 | PH HEALTH | ANDA 212743 | AB | Apr 29, 2021 | |
| CHLORZOXAZONE×2 | CHARTWELL RX | ANDA 212053 | — | Sep 14, 2020 | |
| CHLORZOXAZONE×3 | DR REDDYS LABS SA | ANDA 211849 | AB | Jul 21, 2020 | |
| CHLORZOXAZONE×2 | TEVA PHARMS USA INC | ANDA 212898 | — | Jun 17, 2020 | |
| CHLORZOXAZONE×2 | GLENMARK PHARMS LTD | ANDA 212185 | — | May 26, 2020 | |
| CHLORZOXAZONE×2 | NOVITIUM PHARMA | ANDA 212253 | AB | Nov 27, 2019 | |
| CHLORZOXAZONE | NOVITIUM PHARMA | ANDA 212254 | AA | Sep 12, 2019 | |
| CHLORZOXAZONE | ANDA REPOSITORY | ANDA 207483 | AA | Jun 24, 2016 | |
| CHLORZOXAZONE×2 | ANDA REPOSITORY | ANDA 040861 | AB | Jun 01, 2010 | |
| CHLORZOXAZONE | WATSON LABS | ANDA 040137 | — | Aug 09, 1996 | |
| CHLORZOXAZONE | ACTAVIS ELIZABETH | ANDA 040113 | — | Sep 29, 1995 | |
| CHLORZOXAZONE | OHM LABS | ANDA 081298 | — | Dec 29, 1993 | |
| CHLORZOXAZONE | OHM LABS | ANDA 081299 | — | Dec 29, 1993 | |
| CHLORZOXAZONE | WATSON LABS | ANDA 081019 | — | Jul 29, 1991 | |
| CHLORZOXAZONE | SUN PHARM INDUSTRIES | ANDA 089970 | — | Sep 27, 1990 | |
| CHLORZOXAZONE | WATSON LABS | ANDA 081040 | — | Aug 22, 1989 | |
| CHLORZOXAZONE | PIONEER PHARMS | ANDA 089592 | — | Jan 06, 1989 | |
| CHLORZOXAZONE | PIONEER PHARMS | ANDA 089948 | — | Jan 06, 1989 | |
| STRIFON FORTE DSC | FERNDALE LABS | ANDA 081008 | — | Dec 23, 1988 | |
| CHLORZOXAZONE | BARR | ANDA 089895 | — | May 04, 1988 | |
| CHLORZOXAZONE | RISING | ANDA 089852 | — | May 04, 1988 | |
| CHLORZOXAZONE | WATSON LABS | ANDA 089859 | AA | May 04, 1988 | |
| CHLORZOXAZONE | ACTAVIS ELIZABETH | ANDA 088928 | — | May 08, 1987 | |
| CHLORZOXAZONE | CHARTWELL RX | ANDA 087981 | — | Sep 20, 1983 | |
| CHLORZOXAZONE | WATSON LABS | ANDA 086948 | — | Aug 09, 1982 | |
| CHLORZOXAZONE | WATSON LABS | ANDA 086901 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Chlorzoxazone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
