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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021060
Company: TERSERA

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/16/2023 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021060s012lbl.pdf
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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