Testosterone Nasal Gel

Brand(s)
Natesto
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Endo Pharmaceuticals Inc. (2015-05-20)
Oldest Current Product
2015-03-12
License(s)
NDA
RxNORM
NASAL GEL\TESTOSTERONE
FDAOB
NASAL\GEL, METERED\TESTOSTERONE
SPL Active
NASAL\GEL\TESTOSTERONE
SPL Moiety
NASAL\GEL\TESTOSTERONE

product(s) by strength(s)

60 actuat testosterone 5.5 mg/actuat nasal gel

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634810239NatestoNDAEndo Pharmaceuticals Inc.2015-03-12TESTOSTERONENASALGELNDA205488b0343bcc-7320-4bf2-bcb3-d95b6f4ba5fe

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205488NATESTOENDO VENTURES LTD2014-05-28p8877230, NASAL ADMINISTRATION OF A TESTOSTERONE GEL TO A PATIENT TO TREAT THE PATIENT FOR A CONDITION ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
p8784882, A METHOD OF TESTOSTERONE REPLACEMENT THERAPY COMPRISING THE STEP OF NASALLY ADMINISTERING TO A PATIENT IN NEED OF SUCH TREATMENT AN EFFECTIVE AMOUNT OF TESTOSTERONE GEL FORMULATION., SUBSTANCE
p8784869, SUBSTANCE
p8574622, SUBSTANCE
NEW PRODUCT [2017-05-28]NDA205488_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205488_001RXTESTOSTERONE (5.5MG/0.122GM ACTUATION)NASALGEL, METEREDFalse2014-05-28NATESTO

patent(s)

#idexpiration dateapplication(s)
1p8574622 (view patent)2024-02-04NDA205488
2p8784869 (view patent)2024-02-04NDA205488
3p8784882 (view patent)2024-02-04NDA205488
4p8877230 (view patent)2024-02-04NDA205488

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1b0343bcc-7320-4bf2-bcb3-d95b6f4ba5fe (view SPL)These highlights do not include all the information needed to useNatesto safely and effectively. See full prescribing information for Natesto. Natesto[testosterone) nasal gel CIII Initial U.S. Approval: 1953prescriptionHuman PrescriptionEndo Pharmaceuticals Inc.2015-05-206634810239

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII