Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075417
Company: MYLAN
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
CLOZAPINE CLOZAPINE 200MG 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
05/27/1999 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75417ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075417_clozapine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/25/2017 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

04/25/2017 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

04/25/2017 SUPPL-38 Labeling-Container/Carton Labels

Label is not available on this site.

09/15/2015 SUPPL-37 REMS-Proposal

Label is not available on this site.

09/14/2015 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

12/13/2014 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

12/13/2014 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

08/26/2013 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

05/20/2013 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

04/11/2011 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

04/30/2010 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

04/15/2010 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.pdf
04/15/2010 SUPPL-24 Efficacy-New Dosing Regimen Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.pdf
04/08/2009 SUPPL-22 Labeling

Label is not available on this site.

04/15/2010 SUPPL-21 Efficacy-New Dosing Regimen Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.pdf
11/19/2008 SUPPL-18 Labeling

Label is not available on this site.

10/31/2006 SUPPL-11 Labeling

Label is not available on this site.

10/13/2006 SUPPL-10 Labeling

Label is not available on this site.

04/08/2005 SUPPL-9 Labeling

Label is not available on this site.

03/31/2003 SUPPL-6 Labeling

Label is not available on this site.

03/17/2003 SUPPL-4 Labeling

Label is not available on this site.

03/12/2001 SUPPL-1 Labeling

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

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

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