Orange Book product · Brand (NDA)
TRANXENE
CLORAZEPATE DIPOTASSIUM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CLORAZEPATE DIPOTASSIUM
Strength
3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 017105
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2022CLORAZEPATE DIPOTASSIUMGeneric (ANDA)
ANDA 213730 · NOVITIUM PHARMA
- 2022CLORAZEPATE DIPOTASSIUMGeneric (ANDA)
ANDA 215566 · COREPHARMA
- 1990CLORAZEPATE DIPOTASSIUMGeneric (ANDA)
ANDA 072514 · AUROLIFE PHARMA LLC
- 1988CLORAZEPATE DIPOTASSIUMGeneric (ANDA)
ANDA 071549 · QUANTUM PHARMICS
- 1988CLORAZEPATE DIPOTASSIUMGeneric (ANDA)
ANDA 071550 · QUANTUM PHARMICS
- 1988CLORAZEPATE DIPOTASSIUMGeneric (ANDA)
ANDA 071522 · QUANTUM PHARMICS
- 1988CLORAZEPATE DIPOTASSIUMGeneric (ANDA)
ANDA 072112 · RISING
- 1988CLORAZEPATE DIPOTASSIUMGeneric (ANDA)
ANDA 072330 · PUREPAC PHARM
- 1988CLORAZEPATE DIPOTASSIUMGeneric (ANDA)
ANDA 072331 · PUREPAC PHARM
- 1988CLORAZEPATE DIPOTASSIUMGeneric (ANDA)
ANDA 072332 · PUREPAC PHARM
- 1988CLORAZEPATE DIPOTASSIUMGeneric (ANDA)
ANDA 071924 · PUREPAC PHARM
- 1988CLORAZEPATE DIPOTASSIUMGeneric (ANDA)
ANDA 071925 · PUREPAC PHARM
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.
