Orange Book product · Generic (ANDA)
CLOZAPINE
CLOZAPINE
At a glance
Dec 16, 2005
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 16, 2005
20 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOZAPINE
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 076809
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CLOZAPINE
- 2013VERSACLOZBrand (NDA)
NDA 203479 · DOUGLAS PHARMS
- 2007FAZACLO ODTBrand (NDA)
NDA 021590 · JAZZ
- 1989CLOZARILBrand (NDA)
NDA 019758 · HERITAGE LIFE
- 2024CLOZAPINEGeneric (ANDA)
ANDA 212923 · AUROBINDO PHARMA
- 2018CLOZAPINEGeneric (ANDA)
ANDA 090308 · BARR LABS INC
- 2017CLOZAPINEGeneric (ANDA)
ANDA 209480 · ZYDUS PHARMS
- 2016CLOZAPINEGeneric (ANDA)
ANDA 206433 · AUROBINDO PHARMA
- 2015CLOZAPINEGeneric (ANDA)
ANDA 202873 · ACCORD HLTHCARE
- 2015CLOZAPINEGeneric (ANDA)
ANDA 203807 · DR REDDYS LABS SA
- 2015CLOZAPINEGeneric (ANDA)
ANDA 201824 · MYLAN
- 2010CLOZAPINEGeneric (ANDA)
ANDA 075417 · MYLAN
- 2005CLOZAPINEGeneric (ANDA)
ANDA 075162 · PAR 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.
