ulipristal Oral Tablet

Brand(s)
Ella
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Afaxys Inc. (2014-07-01)
Oldest Current Product
2010-08-13
License(s)
NDA
RxNORM
ORAL TABLET\ULIPRISTAL
FDAOB
ORAL\TABLET\ULIPRISTAL ACETATE
SPL Active
ORAL\TABLET\ULIPRISTAL ACETATE
SPL Moiety
ORAL\TABLET\ULIPRISTAL

product(s) by strength(s)

ulipristal acetate 30 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1501020911EllaNDAAfaxys Inc.2010-08-13ULIPRISTAL ACETATEORALTABLETNDA022474052bfe45-c485-49e5-8fc4-51990b2efba4

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022474ELLALABORATOIRE HRA PHARMA2010-08-13p8735380, SUBSTANCE
p8962603, METHOD FOR PROVIDING POST COITAL CONTRACEPTION TO A WOMAN BY ADMINISTERING ABOUT 30 MG OF ULIPRISTAL ACETATE WITHIN ABOUT 120 HOURS AFTER INTERCOURSE
p8426392, ELLA IS AN PROGESTERONE AGONIST/ANTAGONIST EMERGENCY CONTRACEPTION INDICATED FOR THE PREVENTION OF PREGNANCY FOLLOWING UNPROTECTED INTERCOURSE OR A KNOWN OR SUSPECTED CONTRACEPTIVE FAILURE. ELLA CAN BE TAKEN WITH OR WITHOUT FOOD
p8512745, SUBSTANCE
NEW CHEMICAL ENTITY [2015-08-13]NDA022474_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022474_001RXULIPRISTAL ACETATE (30MG)ORALTABLETTrue2010-08-13ELLA

patent(s)

#idexpiration dateapplication(s)
1p8426392 (view patent)2030-06-12NDA022474
2p8512745 (view patent)2030-06-02NDA022474
3p8735380 (view patent)2029-02-20NDA022474
4p8962603 (view patent)2030-06-12NDA022474

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1052bfe45-c485-49e5-8fc4-51990b2efba4 (view SPL)These highlights do not include all the information needed to use ella safety and effectively. See full prescribing information for ella. ella(ulipristal acetate) tablet Initial U.S. Approval: 2010prescriptionHuman PrescriptionAfaxys Inc.api manufacture, api/fdf analytical testing, fdf manufacture, pack2014-07-012501020911

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