Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075713
Company: SUN PHARM INDS INC
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 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
11/15/2002 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
06/29/2017 SUPPL-41 Labeling-Package Insert

Label is not available on this site.

06/29/2017 SUPPL-39 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/29/2017 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

09/15/2015 SUPPL-36 REMS-Proposal

Label is not available on this site.

06/26/2014 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

12/27/2011 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

07/11/2011 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

04/05/2011 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

02/25/2010 SUPPL-25 Labeling-Patient Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/17/2009 SUPPL-22 Labeling

Label is not available on this site.

08/19/2008 SUPPL-18 Labeling

Label is not available on this site.

10/13/2006 SUPPL-12 Labeling

Label is not available on this site.

10/13/2006 SUPPL-11 Labeling

Label is not available on this site.

06/30/2006 SUPPL-9 Labeling

Label is not available on this site.

03/13/2006 SUPPL-7 Labeling

Label is not available on this site.

08/19/2005 SUPPL-6 Labeling

Label is not available on this site.

08/19/2005 SUPPL-5 Manufacturing (CMC)-New Strength

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; 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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