Orange Book product · Brand (NDA)
CLOZARIL
CLOZAPINE
At a glance
Sep 26, 1989
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 26, 1989
37 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOZAPINE
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 019758
Product number
001
Marketing status
RX
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
- 2007FAZACLO ODTBrand (NDA)
NDA 021590 · JAZZ
- 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.
