FDA Orange Book · active-ingredient family
Clorazepate dipotassium
Clorazepate dipotassium is approved as 1 brand and 61 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TRANXENE · NDA 017105
1
Brand (NDA)
61
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRANXENERLD×8 | AJENAT PHARMS | NDA 017105 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (61)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLORAZEPATE DIPOTASSIUM×3 | NOVITIUM PHARMA | ANDA 213730 | AB | Jun 16, 2022 | |
| CLORAZEPATE DIPOTASSIUM×3 | COREPHARMA | ANDA 215566 | AB | Jun 14, 2022 | |
| CLORAZEPATE DIPOTASSIUM×3 | SUN PHARM INDS LTD | ANDA 076911 | — | Sep 29, 2004 | |
| CLORAZEPATE DIPOTASSIUM×3 | TARO | ANDA 075731 | AB | Apr 27, 2000 | |
| CLORAZEPATE DIPOTASSIUM×3 | AUROLIFE PHARMA LLC | ANDA 072514 | — | May 11, 1990 | |
| CLORAZEPATE DIPOTASSIUM | QUANTUM PHARMICS | ANDA 071549 | — | Sep 12, 1988 | |
| CLORAZEPATE DIPOTASSIUM | QUANTUM PHARMICS | ANDA 071550 | — | Sep 12, 1988 | |
| CLORAZEPATE DIPOTASSIUM | QUANTUM PHARMICS | ANDA 071522 | — | Sep 12, 1988 | |
| CLORAZEPATE DIPOTASSIUM×3 | RISING | ANDA 072112 | — | Aug 26, 1988 | |
| CLORAZEPATE DIPOTASSIUM | PUREPAC PHARM | ANDA 072330 | — | Aug 08, 1988 | |
| CLORAZEPATE DIPOTASSIUM | PUREPAC PHARM | ANDA 072331 | — | Aug 08, 1988 | |
| CLORAZEPATE DIPOTASSIUM | PUREPAC PHARM | ANDA 072332 | — | Aug 08, 1988 | |
| GEN-XENE | ALRA | ANDA 071787 | — | Apr 26, 1988 | |
| GEN-XENE | ALRA | ANDA 071788 | — | Apr 26, 1988 | |
| GEN-XENE | ALRA | ANDA 071789 | — | Apr 26, 1988 | |
| CLORAZEPATE DIPOTASSIUM | PUREPAC PHARM | ANDA 071924 | — | Apr 25, 1988 | |
| CLORAZEPATE DIPOTASSIUM | PUREPAC PHARM | ANDA 071925 | — | Apr 25, 1988 | |
| CLORAZEPATE DIPOTASSIUM | PUREPAC PHARM | ANDA 071926 | — | Apr 25, 1988 | |
| CLORAZEPATE DIPOTASSIUM | WATSON LABS | ANDA 071878 | — | Mar 15, 1988 | |
| CLORAZEPATE DIPOTASSIUM | WATSON LABS | ANDA 071879 | — | Mar 15, 1988 | |
| CLORAZEPATE DIPOTASSIUM | WATSON LABS | ANDA 071860 | — | Mar 15, 1988 | |
| CLORAZEPATE DIPOTASSIUM | WARNER CHILCOTT | ANDA 071828 | — | Mar 03, 1988 | |
| CLORAZEPATE DIPOTASSIUM | WARNER CHILCOTT | ANDA 071829 | — | Mar 03, 1988 | |
| CLORAZEPATE DIPOTASSIUM | WARNER CHILCOTT | ANDA 071830 | — | Mar 03, 1988 | |
| CLORAZEPATE DIPOTASSIUM | WARNER CHILCOTT | ANDA 071774 | — | Mar 01, 1988 | |
| CLORAZEPATE DIPOTASSIUM | WARNER CHILCOTT | ANDA 071775 | — | Mar 01, 1988 | |
| CLORAZEPATE DIPOTASSIUM | WARNER CHILCOTT | ANDA 071776 | — | Mar 01, 1988 | |
| CLORAZEPATE DIPOTASSIUM | WATSON LABS | ANDA 071852 | — | Feb 09, 1988 | |
| CLORAZEPATE DIPOTASSIUM | WATSON LABS | ANDA 071853 | — | Feb 09, 1988 | |
| CLORAZEPATE DIPOTASSIUM | WATSON LABS | ANDA 071854 | — | Feb 09, 1988 | |
| CLORAZEPATE DIPOTASSIUM | GD SEARLE LLC | ANDA 071727 | — | Dec 18, 1987 | |
| CLORAZEPATE DIPOTASSIUM | GD SEARLE LLC | ANDA 071728 | — | Dec 18, 1987 | |
| CLORAZEPATE DIPOTASSIUM | GD SEARLE LLC | ANDA 071729 | — | Dec 18, 1987 | |
| CLORAZEPATE DIPOTASSIUM | LEDERLE | ANDA 072013 | — | Dec 15, 1987 | |
| CLORAZEPATE DIPOTASSIUM | LEDERLE | ANDA 072014 | — | Dec 15, 1987 | |
| CLORAZEPATE DIPOTASSIUM | LEDERLE | ANDA 072015 | — | Dec 15, 1987 | |
| CLORAZEPATE DIPOTASSIUM | DAVA PHARMS INC | ANDA 071742 | — | Dec 14, 1987 | |
| CLORAZEPATE DIPOTASSIUM | DAVA PHARMS INC | ANDA 071743 | — | Dec 14, 1987 | |
| CLORAZEPATE DIPOTASSIUM | DAVA PHARMS INC | ANDA 071744 | — | Dec 14, 1987 | |
| CLORAZEPATE DIPOTASSIUM | QUANTUM PHARMICS | ANDA 071730 | — | Oct 26, 1987 | |
| CLORAZEPATE DIPOTASSIUM | QUANTUM PHARMICS | ANDA 071731 | — | Oct 26, 1987 | |
| CLORAZEPATE DIPOTASSIUM | QUANTUM PHARMICS | ANDA 071702 | — | Oct 26, 1987 | |
| CLORAZEPATE DIPOTASSIUM | NATCO PHARMA USA | ANDA 071509 | — | Oct 19, 1987 | |
| CLORAZEPATE DIPOTASSIUM | NATCO PHARMA USA | ANDA 071510 | — | Oct 19, 1987 | |
| CLORAZEPATE DIPOTASSIUM | NATCO PHARMA USA | ANDA 071511 | — | Oct 19, 1987 | |
| CLORAZEPATE DIPOTASSIUM×3 | AUROBINDO PHARMA | ANDA 071858 | AB | Jul 17, 1987 | |
| CLORAZEPATE DIPOTASSIUM | ABLE | ANDA 071777 | — | Jul 14, 1987 | |
| CLORAZEPATE DIPOTASSIUM | ABLE | ANDA 071778 | — | Jul 14, 1987 | |
| CLORAZEPATE DIPOTASSIUM | ABLE | ANDA 071779 | — | Jul 14, 1987 | |
| CLORAZEPATE DIPOTASSIUM | ABLE | ANDA 071780 | — | Jun 26, 1987 | |
| CLORAZEPATE DIPOTASSIUM | ABLE | ANDA 071781 | — | Jun 26, 1987 | |
| CLORAZEPATE DIPOTASSIUM | ABLE | ANDA 071782 | — | Jun 26, 1987 | |
| CLORAZEPATE DIPOTASSIUM | AM THERAP | ANDA 071429 | — | Jun 23, 1987 | |
| CLORAZEPATE DIPOTASSIUM | AM THERAP | ANDA 071430 | — | Jun 23, 1987 | |
| CLORAZEPATE DIPOTASSIUM | AM THERAP | ANDA 071431 | — | Jun 23, 1987 | |
| CLORAZEPATE DIPOTASSIUM | USL PHARMA | ANDA 071242 | — | Jun 23, 1987 | |
| CLORAZEPATE DIPOTASSIUM | USL PHARMA | ANDA 071243 | — | Jun 23, 1987 | |
| CLORAZEPATE DIPOTASSIUM | USL PHARMA | ANDA 071244 | — | Jun 23, 1987 | |
| CLORAZEPATE DIPOTASSIUM | AM THERAP | ANDA 071747 | — | Jun 23, 1987 | |
| CLORAZEPATE DIPOTASSIUM | AM THERAP | ANDA 071748 | — | Jun 23, 1987 | |
| CLORAZEPATE DIPOTASSIUM | AM THERAP | ANDA 071749 | — | Jun 23, 1987 |
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.
Clorazepate dipotassium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

