FDA Orange Book · active-ingredient family
Chlordiazepoxide hydrochloride
Chlordiazepoxide hydrochloride is approved as 2 brand and 77 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LIBRIUM · NDA 012249
2
Brand (NDA)
77
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LIBRIUMRLD×3 | VALEANT PHARM INTL | NDA 012249 | — | Approved Prior to Jan 1, 1982 | |
| LIBRIUM | BAUSCH | NDA 012301 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (77)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE HYDROCHLORIDE | PIONEER PHARMS | ANDA 089533 | — | Jul 15, 1988 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | PIONEER PHARMS | ANDA 089558 | — | Jul 15, 1988 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | SUPERPHARM | ANDA 088987 | — | Apr 25, 1985 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | SUPERPHARM | ANDA 088986 | — | Apr 25, 1985 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | SUPERPHARM | ANDA 088988 | — | Apr 25, 1985 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | TEVA | ANDA 088705 | — | Jan 18, 1985 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | TEVA | ANDA 088706 | — | Jan 18, 1985 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | TEVA | ANDA 088707 | — | Jan 18, 1985 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | VANGARD | ANDA 088129 | — | Mar 28, 1983 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | VANGARD | ANDA 088010 | — | Mar 28, 1983 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | VANGARD | ANDA 088130 | — | Mar 28, 1983 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | ASCOT | ANDA 087525 | — | Jan 07, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | ASCOT | ANDA 087524 | — | Jan 07, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | ASCOT | ANDA 087512 | — | Jan 07, 1982 | |
| A-POXIDE×3 | ABBOTT | ANDA 085447 | — | Approved Prior to Jan 1, 1982 | |
| A-POXIDE | ABBOTT | ANDA 085517 | — | Approved Prior to Jan 1, 1982 | |
| A-POXIDE | ABBOTT | ANDA 085518 | — | Approved Prior to Jan 1, 1982 | |
| A-POXIDE | ABBOTT | ANDA 085513 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZACHEL | RACHELLE | ANDA 085086 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZACHEL | RACHELLE | ANDA 084639 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZACHEL | RACHELLE | ANDA 085087 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDERLD | BARR | ANDA 084768 | AB | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDERLD | BARR | ANDA 083116 | AB | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDERLD | BARR | ANDA 084769 | AB | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | CHARTWELL RX | ANDA 084678 | AB | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | CHARTWELL RX | ANDA 084041 | AB | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | CHARTWELL RX | ANDA 084679 | AB | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | FERRANTE | ANDA 085118 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | FERRANTE | ANDA 085119 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | FERRANTE | ANDA 085120 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | HALSEY | ANDA 085340 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | HALSEY | ANDA 085339 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | HALSEY | ANDA 084685 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | IMPAX LABS | ANDA 086213 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | IMPAX LABS | ANDA 085113 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | IMPAX LABS | ANDA 086212 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | IVAX SUB TEVA PHARMS | ANDA 083741 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | IVAX SUB TEVA PHARMS | ANDA 083742 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | IVAX SUB TEVA PHARMS | ANDA 083570 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | LEDERLE | ANDA 086892 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | LEDERLE | ANDA 087234 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | LEDERLE | ANDA 086876 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | LEDERLE | ANDA 087037 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | LEDERLE | ANDA 086893 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | LEDERLE | ANDA 087231 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | MAST MM | ANDA 086217 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | MYLAN | ANDA 084886 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | MYLAN | ANDA 084601 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | MYLAN | ANDA 084887 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | PARKE DAVIS | ANDA 085163 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | PARKE DAVIS | ANDA 084598 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | PARKE DAVIS | ANDA 085164 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | PUREPAC PHARM | ANDA 085155 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | PUREPAC PHARM | ANDA 084939 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | PUREPAC PHARM | ANDA 085144 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | ROXANE | ANDA 084706 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | ROXANE | ANDA 084700 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | ROXANE | ANDA 084705 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | TEVA | ANDA 086494 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | UPSHER SMITH LABS | ANDA 084919 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDERLD | UPSHER SMITH LABS | ANDA 084920 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | UPSHER SMITH LABS | ANDA 084823 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | USL PHARMA | ANDA 084644 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | USL PHARMA | ANDA 084623 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | USL PHARMA | ANDA 084645 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | WATSON LABS | ANDA 086383 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | WATSON LABS | ANDA 086294 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | WATSON LABS | ANDA 086382 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | WEST WARD | ANDA 085014 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | WEST WARD | ANDA 085000 | — | Approved Prior to Jan 1, 1982 | |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | WEST WARD | ANDA 085294 | — | Approved Prior to Jan 1, 1982 | |
| LIBRIUMRLD | BAUSCH | ANDA 085461 | AB | Approved Prior to Jan 1, 1982 | |
| LIBRIUMRLD | BAUSCH | ANDA 085472 | AB | Approved Prior to Jan 1, 1982 | |
| LIBRIUMRLD | BAUSCH | ANDA 085475 | AB | Approved Prior to Jan 1, 1982 | |
| LYGEN | ALRA | ANDA 085107 | — | Approved Prior to Jan 1, 1982 | |
| LYGEN | ALRA | ANDA 085009 | — | Approved Prior to Jan 1, 1982 | |
| LYGEN | ALRA | ANDA 085108 | — | 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.
Chlordiazepoxide hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

