Paroxetine Oral Capsule

Brand(s)
Brisdelle
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Noven Therapeutics, Llc (2014-12-04)
Oldest Current Product
2013-06-28
License(s)
NDA
RxNORM
ORAL CAPSULE\PAROXETINE
FDAOB
ORAL\CAPSULE\PAROXETINE MESYLATE
SPL Active
ORAL\CAPSULE\PAROXETINE MESYLATE
SPL Moiety
ORAL\CAPSULE\PAROXETINE

product(s) by strength(s)

paroxetine 7.5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1689689075BrisdelleNDANoven Therapeutics, Llc2013-06-28PAROXETINE MESYLATEORALCAPSULENDA204516bf208751-e6d8-11e1-aff1-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204516BRISDELLENOVEN THERAPEUTICS LLC2013-06-28p8658663, TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE, SUBSTANCE
p8946251, TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE, SUBSTANCE
p5874447
p7598271
NEW PRODUCT [2016-06-28]NDA204516_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204516_001RXPAROXETINE MESYLATE (EQ 7.5MG BASE)ORALCAPSULETrue2013-06-28BRISDELLE

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5874447 (view patent)2017-06-10NDA204516, NDA021299Paroxetine Oral Tablet
2p7598271 (view patent)2023-02-12NDA204516, NDA021299Paroxetine Oral Tablet
3p8658663 (view patent)2029-04-06NDA204516
4p8946251 (view patent)2026-08-04NDA204516

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1bf208751-e6d8-11e1-aff1-0800200c9a66 (view SPL)These highlights do not include all the information needed to use BRISDELLE safely and effectively. See full prescribing information for BRISDELLE. BRISDELLE (paroxetine) capsules, for oral use Initial U.S. Approval: 1992prescriptionHuman PrescriptionNoven Therapeutics, LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-12-046689689075

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