Paroxetine Oral Suspension

Brand(s)
Paxil
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Apotex Corp (2014-07-29)
Oldest Current Product
2011-01-01
License(s)
NDA
RxNORM
ORAL SUSPENSION\PAROXETINE
FDAOB
ORAL\SUSPENSION\PAROXETINE HYDROCHLORIDE
SPL Active
ORAL\SUSPENSION\PAROXETINE HYDROCHLORIDE HEMIHYDRATE
SPL Moiety
ORAL\SUSPENSION\PAROXETINE

product(s) by strength(s)

paroxetine 2 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1605050402PaxilNDAApotex Corp2011-01-01PAROXETINE HYDROCHLORIDE HEMIHYDRATEORALSUSPENSIONNDA020710584ace29-6e40-432f-950f-ab7e98653d32

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA077395PAROXETINE HYDROCHLORIDETrueAPOTEX INC2006-12-05ANDA077395_001
2NDA020710PAXILAPOTEX TECHNOLOGIES INC1997-06-25p6133289, DEPRESSION
p5811436
p5900423
p6121291, POSTTRAUMATIC STRESS DISORDER/ DEPRESSION
p5872132
NDA020710_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077395_001discontinuedPAROXETINE HYDROCHLORIDE (EQ 10MG BASE/5ML)ORALSUSPENSIONFalse2006-12-05PAROXETINE HYDROCHLORIDE
2NDA020710_001RXPAROXETINE HYDROCHLORIDE (EQ 10MG BASE/5ML)ORALSUSPENSIONTrueAB1997-06-25PAXIL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5811436 (view patent)2015-09-22NDA020710
2p5872132 (view patent)2015-05-19NDA020710, NDA020031, NDA020885, NDA020936Paroxetine Oral Tablet
Paroxetine Extended Release Oral Tablet
3p5900423 (view patent)2015-05-19NDA020710, NDA020031, NDA020885, NDA020936Paroxetine Oral Tablet
Paroxetine Extended Release Oral Tablet
4p6121291 (view patent)2017-03-17NDA020710, NDA020031, NDA020885, NDA020936Paroxetine Oral Tablet
Paroxetine Extended Release Oral Tablet
5p6133289 (view patent)2015-05-19NDA020710, NDA020031, NDA020885, NDA020936Paroxetine Oral Tablet
Paroxetine Extended Release Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
1584ace29-6e40-432f-950f-ab7e98653d32 (view SPL)PAXIL (paroxetine hydrochloride) Tablets and Oral SuspensionprescriptionHuman PrescriptionApotex Corp2014-07-299605050402, 605053663, 605053664, 605053665, 605053666Paroxetine Oral Tablet

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