FDA.reportPublic FDA data

Application 021166

Type
NDA
Sponsor
ASCEND THERAPS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTROGELESTRADIOLGEL;TOPICAL0.06%NoNo
002ESTROGELESTRADIOLGEL, METERED;TRANSDERMAL0.06% (1.25GM/ACTIVATION)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17139-613EstroGelestradiolASCEND Therapeutics US, LLCNDACurrent
17139-617EstroGelestradiolASCEND Therapeutics US, LLCNDACurrent
17139-617EstroGelestradiolASCEND Therapeutics US, LLCNDACurrent
17139-617EstroGelestradiolASCEND Therapeutics US, LLCNDACurrent
17139-617EstroGelestradiolASCEND Therapeutics US, LLCNDACurrent
17139-617EstroGelestradiolASCEND Therapeutics US, LLCNDACurrent
17139-617EstroGelestradiolASCEND Therapeutics US, LLCNDACurrent
17139-617EstroGelestradiolASCEND Therapeutics US, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77578SUPPL 2024-02-20
77555SUPPL 2024-02-16
74979SUPPL 2023-08-03
74974SUPPL 2023-08-02
69464SUPPL2021-12-03
69439SUPPL2021-12-01
50275SUPPL2017-11-02
26956SUPPL2014-03-27
14545SUPPL2014-03-27
14544SUPPL2008-01-30
26955SUPPL2008-01-29
4519SUPPL2007-07-30
36254SUPPL2007-07-27
41999ORIG2005-06-23
26954SUPPL2004-09-15
14543ORIG2004-04-05
4518ORIG2004-03-02