FDA.reportPublic FDA data

Application 021060

Type
NDA
Sponsor
TERSERA THERAPS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRIALTZICONOTIDE ACETATEINJECTABLE;INTRATHECAL500MCG/20ML (25MCG/ML)YesYes
002PRIALTZICONOTIDE ACETATEINJECTABLE;INTRATHECAL100MCG/1ML (100MCG/ML)YesYes
003PRIALTZICONOTIDE ACETATEINJECTABLE;INTRATHECAL200MCG/2ML (100MCG/ML)NoNo
004PRIALTZICONOTIDE ACETATEINJECTABLE;INTRATHECAL500MCG/5ML (100MCG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
18860-720PrialtziconotideJazz Pharmaceuticals, Inc.NDACurrent
18860-722PrialtziconotideJazz Pharmaceuticals, Inc.NDACurrent
18860-723PrialtziconotideJazz Pharmaceuticals, Inc.NDACurrent
70720-720PRIALTziconotide acetateTerSera Therapeutics LLCNDACurrent
70720-720PRIALTziconotide acetateTerSera Therapeutics LLCNDACurrent
70720-720PRIALTziconotide acetateTerSera Therapeutics LLCNDACurrent
70720-722PRIALTziconotide acetateTerSera Therapeutics LLCNDACurrent
70720-722PRIALTziconotide acetateTerSera Therapeutics LLCNDACurrent
70720-722PRIALTziconotide acetateTerSera Therapeutics LLCNDACurrent
70720-723PRIALTziconotide acetateTerSera Therapeutics LLCNDACurrent
70720-723PRIALTziconotide acetateTerSera Therapeutics LLCNDACurrent
70720-723PRIALTziconotide acetateTerSera Therapeutics LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74178SUPPL 2023-05-04
26606SUPPL2011-09-06
14261SUPPL2011-09-02
41916SUPPL2007-07-20
26605SUPPL2007-04-25
14260SUPPL2007-04-20
26604SUPPL2005-05-27
21400ORIG2005-04-27
35991ORIG2004-12-29
4181ORIG2004-12-29