sildenafil Oral Suspension

Brand(s)
Revatio
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2015-05-07)
Oldest Current Product
2014-06-02
License(s)
NDA
RxNORM
ORAL SUSPENSION\SILDENAFIL
FDAOB
ORAL\FOR SUSPENSION\SILDENAFIL CITRATE
SPL Active
ORAL\POWDER, FOR SUSPENSION\SILDENAFIL CITRATE
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\SILDENAFIL

product(s) by strength(s)

sildenafil 10 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690336RevatioNDAPfizer Labs2014-06-02SILDENAFIL CITRATEORALPOWDER, FOR SUSPENSIONNDA203109f158fe10-d5dc-4432-b2c9-fc665401291b

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA203109REVATIOPFIZER INC2012-08-30NEW DOSAGE FORM [2015-08-30]
NEW LOWER DOSING REGIMEN FOR REVATIO IN THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS [2017-01-31]
INFORMATION ADDED TO THE LABELING REGARDING THE ADDITION OF SILDENAFIL TO BOSENTAN THERAPY [2017-01-31]
PEDIATRIC EXCLUSIVITY [2016-03-01]
NDA203109_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203109_001RXSILDENAFIL CITRATE (EQ 10MG BASE/ML)ORALFOR SUSPENSIONTrue2012-08-30REVATIO

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1f158fe10-d5dc-4432-b2c9-fc665401291b (view SPL)These highlights do not include all the information needed to use REVATIO safely and effectively. See full prescribing information for REVATIO. REVATIO (sildenafil) tablets, for oral use REVATIO (sildenafil) for oral suspension REVATIO (sildenafil) injection, for intravenous use Initial U.S. Approval: 1998prescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-05-0733000690336, 000690338, 000694190sildenafil Oral Tablet
sildenafil Injection

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