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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021060
Company: TERSERA

Products on NDA 021060

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021060

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
03/16/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021060s012lbl.pdf
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

Labels for NDA 021060

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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