Orange Book product · Brand (NDA)
FAZACLO ODT
CLOZAPINE
At a glance
May 30, 2007
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 30, 2007
19 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOZAPINE
Strength
12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 021590
Product number
004
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.
- 2013VERSACLOZBrand (NDA)
NDA 203479 · DOUGLAS PHARMS
- 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
- 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.
