Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021060
Company: TERSERA
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 |