Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203479
Company: TASMAN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERSACLOZ CLOZAPINE 50MG/ML SUSPENSION;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/06/2013 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203479_versacloz_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203479Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203479s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203479Orig1s010ltr.pdf
09/30/2015 SUPPL-9 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s028,203479s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s028,203479Orig1s009ltr.pdf
09/15/2015 SUPPL-8 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203479Orig1s007,s008ltr.pdf
09/15/2015 SUPPL-7 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203479Orig1s007,s008ltr.pdf
02/18/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/29/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/25/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/22/2013 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s002ltr.pdf
12/05/2013 SUPPL-1 REMS-Modified, REMS-Assessment Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479Orig1s001Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/23/2017 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203479s010lbl.pdf
09/30/2015 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s028,203479s009lbl.pdf
09/15/2015 SUPPL-8 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf
09/15/2015 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf
12/05/2013 SUPPL-1 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479Orig1s001Lbl.pdf
12/05/2013 SUPPL-1 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479Orig1s001Lbl.pdf
08/22/2013 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s002lbl.pdf
02/06/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s000lbl.pdf

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