Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076809
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOZAPINE CLOZAPINE 200MG TABLET;ORAL Prescription AB No No
CLOZAPINE CLOZAPINE 100MG 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
12/16/2005 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/2017 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

04/26/2017 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

04/26/2017 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

04/26/2017 SUPPL-32 Labeling-Container/Carton Labels

Label is not available on this site.

04/26/2017 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

09/15/2015 SUPPL-30 REMS-Proposal

Label is not available on this site.

09/14/2015 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

12/08/2014 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

12/08/2014 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

07/31/2013 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

12/28/2011 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

07/27/2011 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

04/11/2011 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

10/19/2010 SUPPL-20 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/08/2009 SUPPL-15 Labeling

Label is not available on this site.

09/23/2008 SUPPL-13 Labeling

Label is not available on this site.

08/19/2008 SUPPL-11 Labeling

Label is not available on this site.

04/03/2008 SUPPL-9 Labeling

Label is not available on this site.

09/26/2014 SUPPL-7 Labeling

Label is not available on this site.

09/26/2014 SUPPL-4 Labeling

Label is not available on this site.

CLOZAPINE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 200MG TABLET;ORAL Prescription No AB 206433 AUROBINDO PHARMA LTD
CLOZAPINE CLOZAPINE 200MG TABLET;ORAL Prescription No AB 076809 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 200MG TABLET;ORAL Prescription No AB 203807 MAYNE PHARMA
CLOZAPINE CLOZAPINE 200MG TABLET;ORAL Prescription No AB 075417 MYLAN
CLOZAPINE CLOZAPINE 200MG TABLET;ORAL Prescription No AB 075713 SUN PHARM INDS INC

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; 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

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