FDA.reportPublic FDA data

Application 206089

Type
NDA
Sponsor
CLARUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JATENZOTESTOSTERONE UNDECANOATECAPSULE;ORAL158MGYesNo
002JATENZOTESTOSTERONE UNDECANOATECAPSULE;ORAL198MGYesNo
003JATENZOTESTOSTERONE UNDECANOATECAPSULE;ORAL237MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69087-158Jatenzotestosterone undecanoateClarus Therapeutics, Inc.NDACurrent
69087-158Jatenzotestosterone undecanoateTOLMAR Inc.NDACurrent
69087-158Jatenzotestosterone undecanoateClarus Therapeutics, Inc.NDACurrent
69087-198Jatenzotestosterone undecanoateClarus Therapeutics, Inc.NDACurrent
69087-198Jatenzotestosterone undecanoateTOLMAR Inc.NDACurrent
69087-198Jatenzotestosterone undecanoateClarus Therapeutics, Inc.NDACurrent
69087-237Jatenzotestosterone undecanoateClarus Therapeutics, Inc.NDACurrent
69087-237Jatenzotestosterone undecanoateTOLMAR Inc.NDACurrent
69087-237Jatenzotestosterone undecanoateClarus Therapeutics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83353SUPPL 2025-09-15
83352SUPPL 2025-09-15
83351SUPPL 2025-09-15
82874SUPPL 2025-07-15
82843SUPPL 2025-07-14
61042ORIG2019-11-25
58130ORIG2019-03-28
58097ORIG2019-03-27