Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074949
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription AB No No
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription AB No No
CLOZAPINE CLOZAPINE 12.5MG TABLET;ORAL Prescription AB No No
CLOZAPINE CLOZAPINE 50MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/26/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74949ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/2017 SUPPL-74 Labeling-Package Insert

Label is not available on this site.

04/26/2017 SUPPL-73 Labeling-Package Insert

Label is not available on this site.

04/26/2017 SUPPL-72 Labeling-Package Insert

Label is not available on this site.

04/26/2017 SUPPL-69 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/26/2017 SUPPL-68 Labeling-Package Insert

Label is not available on this site.

09/15/2015 SUPPL-67 REMS-Proposal

Label is not available on this site.

09/14/2015 SUPPL-66 Labeling-Package Insert

Label is not available on this site.

12/08/2014 SUPPL-65 Labeling-Package Insert

Label is not available on this site.

12/08/2014 SUPPL-64 Labeling-Package Insert

Label is not available on this site.

08/26/2013 SUPPL-63 Labeling-Package Insert

Label is not available on this site.

12/28/2011 SUPPL-61 Labeling-Package Insert

Label is not available on this site.

07/27/2011 SUPPL-60 Labeling-Package Insert

Label is not available on this site.

04/11/2011 SUPPL-59 Labeling-Package Insert

Label is not available on this site.

10/19/2010 SUPPL-58 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/08/2009 SUPPL-52 Labeling

Label is not available on this site.

09/23/2008 SUPPL-50 Labeling

Label is not available on this site.

09/02/2008 SUPPL-49 Labeling

Label is not available on this site.

05/28/2008 SUPPL-47 Labeling

Label is not available on this site.

09/26/2014 SUPPL-44 Labeling

Label is not available on this site.

10/13/2006 SUPPL-41 Labeling

Label is not available on this site.

10/13/2006 SUPPL-40 Labeling

Label is not available on this site.

04/28/2005 SUPPL-34 Labeling

Label is not available on this site.

04/25/2005 SUPPL-31 Labeling

Label is not available on this site.

04/25/2005 SUPPL-30

Label is not available on this site.

07/29/2002 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

09/04/2002 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/31/2003 SUPPL-20 Labeling

Label is not available on this site.

07/31/2003 SUPPL-19 Manufacturing (CMC)-New Strength

Label is not available on this site.

01/28/2000 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

12/14/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/16/1999 SUPPL-12 Labeling

Label is not available on this site.

12/14/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/14/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/14/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/01/1999 SUPPL-8 Labeling

Label is not available on this site.

07/16/1999 SUPPL-7 Labeling

Label is not available on this site.

01/12/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/23/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/24/1998 SUPPL-2 Labeling

Label is not available on this site.

03/27/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLOZAPINE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 202873 ACCORD HLTHCARE
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 206433 AUROBINDO PHARMA LTD
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 074949 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 203807 MAYNE PHARMA
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 075417 MYLAN
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 075713 SUN PHARM INDS INC
CLOZARIL CLOZAPINE 25MG TABLET;ORAL Prescription Yes AB 019758 HERITAGE LIFE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 202873 ACCORD HLTHCARE
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 206433 AUROBINDO PHARMA LTD
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 074949 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 076809 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 203807 MAYNE PHARMA
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 075417 MYLAN
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 075713 SUN PHARM INDS INC
CLOZARIL CLOZAPINE 100MG TABLET;ORAL Prescription Yes AB 019758 HERITAGE LIFE

TABLET;ORAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 12.5MG TABLET;ORAL Prescription No AB 074949 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 12.5MG TABLET;ORAL Prescription No AB 075417 MYLAN

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 50MG TABLET;ORAL Prescription No AB 206433 AUROBINDO PHARMA LTD
CLOZAPINE CLOZAPINE 50MG TABLET;ORAL Prescription No AB 074949 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 50MG TABLET;ORAL Prescription No AB 076809 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 50MG TABLET;ORAL Prescription No AB 203807 MAYNE PHARMA
CLOZAPINE CLOZAPINE 50MG TABLET;ORAL Prescription No AB 075417 MYLAN
CLOZAPINE CLOZAPINE 50MG TABLET;ORAL Prescription No AB 075713 SUN PHARM INDS INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English