tapentadol Oral Solution

Brand(s)
Nucynta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2014-11-25)
Oldest Current Product
2012-10-15
License(s)
NDA
RxNORM
ORAL SOLUTION\TAPENTADOL
FDAOB
ORAL\SOLUTION\TAPENTADOL HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\TAPENTADOL HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\TAPENTADOL

product(s) by strength(s)

tapentadol 20 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580817NucyntaNDAJanssen Pharmaceuticals, Inc.2012-10-15TAPENTADOL HYDROCHLORIDEORALSOLUTIONNDA203794e921054f-b3f1-4624-8edd-f6628c6f0fd9

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA203794NUCYNTADEPOMED INC2012-10-15pRE39593, MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN, SUBSTANCE
p6071970, MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN
p7994364, MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN, SUBSTANCE
NDA203794_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203794_001RXTAPENTADOL HYDROCHLORIDE (EQ 20MG BASE/ML)ORALSOLUTIONTrue2012-10-15NUCYNTA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6071970 (view patent)2017-06-06NDA203794, NDA022304, NDA200533tapentadol Oral Tablet
tapentadol Extended Release Oral Tablet
2p7994364 (view patent)2025-06-27NDA203794, NDA022304, NDA200533tapentadol Oral Tablet
tapentadol Extended Release Oral Tablet
3pRE39593 (view patent)2022-08-05NDA203794, NDA022304, NDA200533tapentadol Oral Tablet
tapentadol Extended Release Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1e921054f-b3f1-4624-8edd-f6628c6f0fd9 (view SPL)These highlights do not include all the information needed to use NUCYNTA safely and effectively. See full prescribing information for NUCYNTA. NUCYNTA (tapentadol) oral solutionC-IIInitial U.S. Approval: 2008prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-11-254504580817

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