Trazodone Extended Release Oral Tablet

Brand(s)
Oleptro
Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2010-02-02
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\TRAZODONE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\TRAZODONE HYDROCHLORIDE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\TRAZODONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\TRAZODONE

product(s) by strength(s)

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1435950080OleptroNDAAngelini Pharma Inc.2010-02-02TRAZODONE HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA02241188c45123-f475-4dd0-bbac-c261868924ef

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1435950081OleptroNDAAngelini Pharma Inc.2010-02-02TRAZODONE HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA02241188c45123-f475-4dd0-bbac-c261868924ef

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1NDA022411OLEPTROTrueANGELINI PHARMA INC2010-02-02p7829120, METHOD OF TREATING DEPRESSION, SUBSTANCE
p6607748, SUBSTANCE
p8133893, SUBSTANCE
NDA022411_001, NDA022411_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022411_001discontinuedTRAZODONE HYDROCHLORIDE (150MG)ORALTABLET, EXTENDED RELEASEFalse2010-02-02OLEPTRO
2NDA022411_002discontinuedTRAZODONE HYDROCHLORIDE (300MG)ORALTABLET, EXTENDED RELEASEFalse2010-02-02OLEPTRO

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6607748 (view patent)2020-06-29NDA022411, NDA021745Tramadol Extended Release Oral Tablet
2p7829120 (view patent)2027-03-27NDA022411
3p8133893 (view patent)2029-03-13NDA022411, NDA018207Trazodone Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
188c45123-f475-4dd0-bbac-c261868924ef (view SPL)These highlights do not include all the information needed to use Oleptro safely and effectively. See full prescribing information for Oleptro.OLEPTRO (trazodone hydrochloride) extended-release tabletsInitial U.S. Approval: 1981prescriptionHuman PrescriptionAngelini Pharma Inc.2014-06-0910435950080, 435950081

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