Orange Book product · Brand (NDA)
KLONOPIN
CLONAZEPAM
At a glance
Apr 09, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 09, 1997
29 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
CLONAZEPAM
Strength
0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 017533
Product number
005
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1997KLONOPIN RAPIDLY DISINTEGRATINGBrand (NDA)
NDA 020813 · ROCHE
- 2026CLONAZEPAMGeneric (ANDA)
ANDA 216988 · RUBICON RESEARCH
- 2019CLONAZEPAMGeneric (ANDA)
ANDA 211033 · ALEMBIC
- 2014CLONAZEPAMGeneric (ANDA)
ANDA 078654 · SUN PHARM INDS INC
- 2006CLONAZEPAMGeneric (ANDA)
ANDA 077856 · PRINSTON INC
- 2005CLONAZEPAMGeneric (ANDA)
ANDA 077194 · BARR
- 2005CLONAZEPAMGeneric (ANDA)
ANDA 077171 · PH HEALTH
- 2005CLONAZEPAMGeneric (ANDA)
ANDA 077147 · ACCORD HLTHCARE
- 2001CLONAZEPAMGeneric (ANDA)
ANDA 075423 · SUN PHARM INDS INC
- 2000CLONAZEPAMGeneric (ANDA)
ANDA 075468 · RUBICON RESEARCH
- 1998CLONAZEPAMGeneric (ANDA)
ANDA 075150 · AUROBINDO PHARMA USA
- 1998CLONAZEPAMGeneric (ANDA)
ANDA 074920 · TEVA
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.
