FDA.reportPublic FDA data

Application 021813

Type
NDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELESTRINESTRADIOLGEL, METERED;TRANSDERMAL0.06% (0.87GM/ACTIVATION)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0037-4801ELESTRINESTRADIOLMeda PharmaceuticalsNDACurrent
0037-4801ELESTRINESTRADIOLMeda PharmaceuticalsNDACurrent
0037-4801ELESTRINESTRADIOLMeda PharmaceuticalsNDACurrent
0037-4801ELESTRINESTRADIOLMeda PharmaceuticalsNDACurrent
0037-4801ELESTRINESTRADIOLMeda PharmaceuticalsNDACurrent
0037-4802ELESTRINESTRADIOLMeda PharmaceuticalsNDACurrent
0037-4802ELESTRINESTRADIOLMeda PharmaceuticalsNDACurrent
0037-4802ELESTRINESTRADIOLMeda PharmaceuticalsNDACurrent
0037-4802ELESTRINESTRADIOLMeda PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77537SUPPL 2024-02-16
77524SUPPL 2024-02-16
65109SUPPL2020-10-30
65108SUPPL2020-10-30
65068SUPPL2020-10-29
65067SUPPL2020-10-29
50270SUPPL2017-11-02
16412SUPPL2014-03-04
6238SUPPL2012-02-29
37689SUPPL2012-02-28
42319ORIG2009-06-09
24217ORIG2009-06-09
6237SUPPL2008-02-29
6236ORIG2006-12-28
16411ORIG2006-12-26