FDA.reportPublic FDA data

Application 020870

Type
NDA
Sponsor
NOVEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COMBIPATCHESTRADIOL; NORETHINDRONE ACETATEFILM, EXTENDED RELEASE;TRANSDERMAL0.05MG/24HR;0.14MG/24HRYesNo
002COMBIPATCHESTRADIOL; NORETHINDRONE ACETATEFILM, EXTENDED RELEASE;TRANSDERMAL0.05MG/24HR;0.25MG/24HRYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68968-0514CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal systemNoven Therapeutics, LLCNDACurrent
68968-0514CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal systemNoven Therapeutics, LLCNDACurrent
68968-0514CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal systemNoven Therapeutics, LLCNDACurrent
68968-0514CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal systemNoven Therapeutics, LLCNDACurrent
68968-0514CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal systemNoven Therapeutics, LLCNDACurrent
68968-0514CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal systemNoven Therapeutics, LLCNDACurrent
68968-0525CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal systemNoven Therapeutics, LLCNDACurrent
68968-0525CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal systemNoven Therapeutics, LLCNDACurrent
68968-0525CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal systemNoven Therapeutics, LLCNDACurrent
68968-0525CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal systemNoven Therapeutics, LLCNDACurrent
68968-0525CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal systemNoven Therapeutics, LLCNDACurrent
68968-0525CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal systemNoven Therapeutics, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77535SUPPL 2024-02-16
77519SUPPL 2024-02-16
50266SUPPL2017-11-02
26095SUPPL2015-05-11
35548SUPPL2015-05-08
35547SUPPL2013-09-24
26094SUPPL2013-09-20
35546SUPPL2005-11-18
26093SUPPL2005-11-18
26092SUPPL2005-01-18
13653SUPPL2005-01-18
35545SUPPL2004-06-23
3624SUPPL2004-06-23
41774ORIG1998-08-07
26091ORIG1998-08-07
13652ORIG1998-08-07