Application 205488

Type
NDA
Sponsor
ACERUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NATESTOTESTOSTERONEGEL, METERED;NASAL5.5MG/0.122GM ACTUATIONNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42667-5511NatestotestosteroneAcerus Pharmaceuticals CorporationNDACurrent
42667-5511NatestotestosteroneAcerus Pharmaceuticals CorporationNDACurrent
42667-5511NatestotestosteroneAcerus Pharmaceuticals CorporationNDACurrent
42667-5511NatestotestosteroneAcerus Pharmaceuticals CorporationNDACurrent
69654-239NatestotestosteroneAytu BioScience, Inc.NDACurrent
69654-239NatestotestosteroneAytu BioScience, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82863SUPPL 2025-07-15
82849SUPPL 2025-07-14
45751SUPPL2016-11-01
45682SUPPL2016-10-27
32680SUPPL2015-05-13
19651SUPPL2015-05-13
44920ORIG2015-01-29
22992ORIG2015-01-29
10453ORIG2014-06-02
40472ORIG2014-05-30