Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021060
Company: TERSERA THERAPS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRIALT ZICONOTIDE ACETATE 500MCG/20ML (25MCG/ML) INJECTABLE;INTRATHECAL Prescription None Yes Yes
PRIALT ZICONOTIDE ACETATE 100MCG/1ML (100MCG/ML) INJECTABLE;INTRATHECAL Prescription None Yes Yes
PRIALT ZICONOTIDE ACETATE 200MCG/2ML (100MCG/ML) INJECTABLE;INTRATHECAL Discontinued None No No
PRIALT ZICONOTIDE ACETATE 500MCG/5ML (100MCG/ML) INJECTABLE;INTRATHECAL 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
12/28/2004 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021060ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-060_Prialt.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2012 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/01/2011 SUPPL-6 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021060s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021060s006ltr.pdf
04/18/2007 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021060s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021060s003_LTR.pdf
05/26/2005 SUPPL-1 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021060s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021060_S001_PRIALT.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/01/2011 SUPPL-6 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021060s006lbl.pdf
04/18/2007 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021060s003lbl.pdf
12/28/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021060lbl.pdf

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