sildenafil Injection

Brand(s)
Revatio
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2015-05-07)
Oldest Current Product
2009-11-18
License(s)
NDA, ANDA
RxNORM
INJECTION\SILDENAFIL
FDAOB
INTRAVENOUS\SOLUTION\SILDENAFIL CITRATE
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\SILDENAFIL CITRATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\SILDENAFIL

product(s) by strength(s)

12.5 ml sildenafil 0.8 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690338RevatioNDAPfizer Labs2009-11-18SILDENAFIL CITRATEINTRAVENOUSINJECTION, SOLUTIONNDA022473f158fe10-d5dc-4432-b2c9-fc665401291b

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1551500166ANDAAuromedics Pharma Llc2015-04-01SILDENAFIL CITRATEINTRAVENOUSINJECTION, SOLUTIONANDA203988bb92d686-a81e-4b91-8048-693af0534cb3

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1ANDA203988SILDENAFIL CITRATEAUROBINDO PHARMA LTD2015-04-01ANDA203988_001
2NDA022473REVATIOPFIZER INC2009-11-18PEDIATRIC EXCLUSIVITY [2016-03-01]
INFORMATION ADDED TO THE LABELING REGARDING THE ADDITION OF SILDENAFIL TO BOSENTAN THERAPY [2017-01-31]
NEW LOWER DOSING REGIMEN FOR REVATIO IN THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS [2017-01-31]
REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST [2015-08-30]
NDA022473_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA203988_001RXSILDENAFIL CITRATE (EQ 10MG BASE/12.5ML)INTRAVENOUSSOLUTIONFalseAP2015-04-01SILDENAFIL CITRATE
2NDA022473_001RXSILDENAFIL CITRATE (EQ 10MG BASE/12.5ML)INTRAVENOUSSOLUTIONTrueAP2009-11-18REVATIO

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1bb92d686-a81e-4b91-8048-693af0534cb3 (view SPL)These highlights do not include all the information needed to use sildenafil injection safely and effectively. See full prescribing information for sildenafil injection. SILDENAFIL injection, for intravenous use Initial U.S. Approval: 1998prescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2015-06-292551500166
2f158fe10-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, PACK2015-05-0733000690338, 000690336, 000694190sildenafil Oral Tablet
sildenafil Oral Suspension

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