Orange Book product · Generic (ANDA)
CLOZAPINE
CLOZAPINE
At a glance
Jul 31, 2003
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 31, 2003
23 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOZAPINE
Strength
12.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 074949
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 076809 · IVAX SUB TEVA PHARMS
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.
