Assyro AI

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

ProductApplicantApplicationTEApproved
TRANXENERLD×8AJENAT PHARMSNDA 017105Approved Prior to Jan 1, 1982

Generic (ANDA) products (61)

ProductApplicantApplicationTEApproved
CLORAZEPATE DIPOTASSIUM×3NOVITIUM PHARMAANDA 213730ABJun 16, 2022
CLORAZEPATE DIPOTASSIUM×3COREPHARMAANDA 215566ABJun 14, 2022
CLORAZEPATE DIPOTASSIUM×3SUN PHARM INDS LTDANDA 076911Sep 29, 2004
CLORAZEPATE DIPOTASSIUM×3TAROANDA 075731ABApr 27, 2000
CLORAZEPATE DIPOTASSIUM×3AUROLIFE PHARMA LLCANDA 072514May 11, 1990
CLORAZEPATE DIPOTASSIUMQUANTUM PHARMICSANDA 071549Sep 12, 1988
CLORAZEPATE DIPOTASSIUMQUANTUM PHARMICSANDA 071550Sep 12, 1988
CLORAZEPATE DIPOTASSIUMQUANTUM PHARMICSANDA 071522Sep 12, 1988
CLORAZEPATE DIPOTASSIUM×3RISINGANDA 072112Aug 26, 1988
CLORAZEPATE DIPOTASSIUMPUREPAC PHARMANDA 072330Aug 08, 1988
CLORAZEPATE DIPOTASSIUMPUREPAC PHARMANDA 072331Aug 08, 1988
CLORAZEPATE DIPOTASSIUMPUREPAC PHARMANDA 072332Aug 08, 1988
GEN-XENEALRAANDA 071787Apr 26, 1988
GEN-XENEALRAANDA 071788Apr 26, 1988
GEN-XENEALRAANDA 071789Apr 26, 1988
CLORAZEPATE DIPOTASSIUMPUREPAC PHARMANDA 071924Apr 25, 1988
CLORAZEPATE DIPOTASSIUMPUREPAC PHARMANDA 071925Apr 25, 1988
CLORAZEPATE DIPOTASSIUMPUREPAC PHARMANDA 071926Apr 25, 1988
CLORAZEPATE DIPOTASSIUMWATSON LABSANDA 071878Mar 15, 1988
CLORAZEPATE DIPOTASSIUMWATSON LABSANDA 071879Mar 15, 1988
CLORAZEPATE DIPOTASSIUMWATSON LABSANDA 071860Mar 15, 1988
CLORAZEPATE DIPOTASSIUMWARNER CHILCOTTANDA 071828Mar 03, 1988
CLORAZEPATE DIPOTASSIUMWARNER CHILCOTTANDA 071829Mar 03, 1988
CLORAZEPATE DIPOTASSIUMWARNER CHILCOTTANDA 071830Mar 03, 1988
CLORAZEPATE DIPOTASSIUMWARNER CHILCOTTANDA 071774Mar 01, 1988
CLORAZEPATE DIPOTASSIUMWARNER CHILCOTTANDA 071775Mar 01, 1988
CLORAZEPATE DIPOTASSIUMWARNER CHILCOTTANDA 071776Mar 01, 1988
CLORAZEPATE DIPOTASSIUMWATSON LABSANDA 071852Feb 09, 1988
CLORAZEPATE DIPOTASSIUMWATSON LABSANDA 071853Feb 09, 1988
CLORAZEPATE DIPOTASSIUMWATSON LABSANDA 071854Feb 09, 1988
CLORAZEPATE DIPOTASSIUMGD SEARLE LLCANDA 071727Dec 18, 1987
CLORAZEPATE DIPOTASSIUMGD SEARLE LLCANDA 071728Dec 18, 1987
CLORAZEPATE DIPOTASSIUMGD SEARLE LLCANDA 071729Dec 18, 1987
CLORAZEPATE DIPOTASSIUMLEDERLEANDA 072013Dec 15, 1987
CLORAZEPATE DIPOTASSIUMLEDERLEANDA 072014Dec 15, 1987
CLORAZEPATE DIPOTASSIUMLEDERLEANDA 072015Dec 15, 1987
CLORAZEPATE DIPOTASSIUMDAVA PHARMS INCANDA 071742Dec 14, 1987
CLORAZEPATE DIPOTASSIUMDAVA PHARMS INCANDA 071743Dec 14, 1987
CLORAZEPATE DIPOTASSIUMDAVA PHARMS INCANDA 071744Dec 14, 1987
CLORAZEPATE DIPOTASSIUMQUANTUM PHARMICSANDA 071730Oct 26, 1987
CLORAZEPATE DIPOTASSIUMQUANTUM PHARMICSANDA 071731Oct 26, 1987
CLORAZEPATE DIPOTASSIUMQUANTUM PHARMICSANDA 071702Oct 26, 1987
CLORAZEPATE DIPOTASSIUMNATCO PHARMA USAANDA 071509Oct 19, 1987
CLORAZEPATE DIPOTASSIUMNATCO PHARMA USAANDA 071510Oct 19, 1987
CLORAZEPATE DIPOTASSIUMNATCO PHARMA USAANDA 071511Oct 19, 1987
CLORAZEPATE DIPOTASSIUM×3AUROBINDO PHARMAANDA 071858ABJul 17, 1987
CLORAZEPATE DIPOTASSIUMABLEANDA 071777Jul 14, 1987
CLORAZEPATE DIPOTASSIUMABLEANDA 071778Jul 14, 1987
CLORAZEPATE DIPOTASSIUMABLEANDA 071779Jul 14, 1987
CLORAZEPATE DIPOTASSIUMABLEANDA 071780Jun 26, 1987
CLORAZEPATE DIPOTASSIUMABLEANDA 071781Jun 26, 1987
CLORAZEPATE DIPOTASSIUMABLEANDA 071782Jun 26, 1987
CLORAZEPATE DIPOTASSIUMAM THERAPANDA 071429Jun 23, 1987
CLORAZEPATE DIPOTASSIUMAM THERAPANDA 071430Jun 23, 1987
CLORAZEPATE DIPOTASSIUMAM THERAPANDA 071431Jun 23, 1987
CLORAZEPATE DIPOTASSIUMUSL PHARMAANDA 071242Jun 23, 1987
CLORAZEPATE DIPOTASSIUMUSL PHARMAANDA 071243Jun 23, 1987
CLORAZEPATE DIPOTASSIUMUSL PHARMAANDA 071244Jun 23, 1987
CLORAZEPATE DIPOTASSIUMAM THERAPANDA 071747Jun 23, 1987
CLORAZEPATE DIPOTASSIUMAM THERAPANDA 071748Jun 23, 1987
CLORAZEPATE DIPOTASSIUMAM THERAPANDA 071749Jun 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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.