Orange Book product · Brand (NDA)
KLONOPIN RAPIDLY DISINTEGRATING
CLONAZEPAM
At a glance
Dec 23, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 1997
28 yr 11 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0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
NDA 020813
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.
- 1997KLONOPINBrand (NDA)
NDA 017533 · CHEPLAPHARM
- 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.
