FDA.reportPublic FDA data

Application 022014

Type
NDA
Sponsor
PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EVAMISTESTRADIOLSPRAY;TRANSDERMAL1.53MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-2067EvamistEstradiolPaddock Laboratories, LLCNDACurrent
0574-2067EvamistEstradiolPadagis US LLCNDACurrent
0574-2067EvamistEstradiolPaddock Laboratories, LLC.NDACurrent
64011-215EvamistestradiolTher-Rx CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77580SUPPL 2024-02-20
77551SUPPL 2024-02-16
75000SUPPL 2023-08-04
74982SUPPL 2023-08-04
50276SUPPL2017-11-02
38086SUPPL2014-03-13
29081SUPPL2014-03-13
38087SUPPL2011-11-01
29082SUPPL2011-10-31
23689ORIG2010-08-09
44663ORIG2009-04-22
42386ORIG2009-04-22
29080SUPPL2008-11-03
29079SUPPL2008-04-16
16772SUPPL2008-04-16
29078ORIG2007-07-31
16771ORIG2007-07-30