FDA.reportPublic FDA data

Application 203696

Type
NDA
Sponsor
ABBVIE ENDOCRINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUPANETA PACKLEUPROLIDE ACETATE; NORETHINDRONE ACETATEINJECTABLE, TABLET;INTRAMUSCULAR, ORAL3.75MG/VIAL,N/A;N/A,5MGYesNo
002LUPANETA PACKLEUPROLIDE ACETATE; NORETHINDRONE ACETATEINJECTABLE, TABLET;INTRAMUSCULAR, ORAL11.25MG/VIAL,N/A;N/A,5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-1052Lupaneta Packleuprolide acetate and norethindrone acetateAbbVie Inc.NDACurrent
0074-1052Lupaneta Packleuprolide acetate and norethindrone acetateAbbVie Inc.NDACurrent
0074-1052Lupaneta Packleuprolide acetate and norethindrone acetateAbbVie Inc.NDACurrent
0074-1052Lupaneta Packleuprolide acetate and norethindrone acetateAbbVie Inc.NDACurrent
0074-1053Lupaneta Packleuprolide acetate and norethindrone acetateAbbVie Inc.NDACurrent
0074-1053Lupaneta Packleuprolide acetate and norethindrone acetateAbbVie Inc.NDACurrent
0074-1053Lupaneta Packleuprolide acetate and norethindrone acetateAbbVie Inc.NDACurrent
0074-1053Lupaneta Packleuprolide acetate and norethindrone acetateAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75034SUPPL 2023-08-10
75033SUPPL 2023-08-10
75032SUPPL 2023-08-10
75029SUPPL 2023-08-10
75028SUPPL 2023-08-10
73361SUPPL 2023-02-02
73353SUPPL 2023-02-01
19490SUPPL2013-11-05
32460SUPPL2013-10-31
24446ORIG2013-09-09
22932ORIG2013-09-09