flibanserin Oral Tablet

Brand(s)
Addyi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sprout Pharmaceuticals, Inc. (2015-08-17)
Oldest Current Product
2015-08-18
License(s)
NDA
RxNORM
ORAL TABLET\FLIBANSERIN
FDAOB
ORAL\TABLET\FLIBANSERIN
SPL Active
ORAL\TABLET, FILM COATED\FLIBANSERIN
SPL Moiety
ORAL\TABLET, FILM COATED\FLIBANSERIN

product(s) by strength(s)

flibanserin 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1586040214AddyiNDASprout Pharmaceuticals, Inc.2015-08-18FLIBANSERINORALTABLET, FILM COATEDNDA0225263819daf3-e935-2c53-c527-e1d57922f394

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022526ADDYISPROUT PHARMACEUTICALS INC2015-08-18p7151103, USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)
p8227471, USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)
p7420057, SUBSTANCE
NEW CHEMICAL ENTITY [2020-08-18]NDA022526_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022526_001RXFLIBANSERIN (100MG)ORALTABLETTrue2015-08-18ADDYI

patent(s)

#idexpiration dateapplication(s)
1p7151103 (view patent)2023-05-09NDA022526
2p7420057 (view patent)2022-08-01NDA022526
3p8227471 (view patent)2023-05-09NDA022526

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13819daf3-e935-2c53-c527-e1d57922f394 (view SPL)These highlights do not include all the information needed to use ADDYI safely and effectively. See full prescribing information for ADDYI. ADDYI (flibanserin) tablets, for oral useInitial U.S. Approval 2015prescriptionHuman PrescriptionSprout Pharmaceuticals, Inc.MANUFACTURE2015-08-173586040214

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