Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022524
Company: MIDATECH PHARMA US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZUPLENZ ONDANSETRON 4MG FILM;ORAL Prescription None Yes No
ZUPLENZ ONDANSETRON 8MG FILM;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
07/02/2010 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/2010/022524s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022524s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022524_zuplenz_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022524Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/25/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/18/2014 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022524s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022524Orig1s003ltr.pdf
10/30/2013 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022524s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022524Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/18/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022524s003lbl.pdf
10/30/2013 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022524s002lbl.pdf
07/02/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022524s000lbl.pdf

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