dalfopristin / quinupristin Injectable Solution

Brand(s)
Synercid
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Laboratories Div Pfizer Inc (2014-09-25)
Oldest Current Product
1999-09-21
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\DALFOPRISTIN:QUINUPRISTIN
FDAOB
IV (INFUSION)\INJECTION\DALFOPRISTIN: QUINUPRISTIN\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DALFOPRISTIN: QUINUPRISTIN
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DALFOPRISTIN: QUINUPRISTIN

product(s) by strength(s)

dalfopristin 70 mg/ml / quinupristin 30 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1615700260SynercidNDAPfizer Laboratories Div Pfizer Inc1999-09-21DALFOPRISTIN, QUINUPRISTININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA05074828f698df-b584-4455-2e94-6efc41313960

application(s)

#idtitleapplicantapprovedapproved drug
1NDA050748SYNERCIDKING PHARMACEUTICALS INC1999-09-21NDA050748_001, NDA050748_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA050748_001RXDALFOPRISTIN (350MG/VIAL), QUINUPRISTIN (150MG/VIAL)INJECTIONTrue1999-09-21SYNERCID
2NDA050748_002discontinuedQUINUPRISTIN (180MG/VIAL), DALFOPRISTIN (420MG/VIAL)INJECTIONFalse2000-08-24SYNERCID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
128f698df-b584-4455-2e94-6efc41313960 (view SPL)Synercid I.V.(quinupristin and dalfopristin for injection)prescriptionHuman PrescriptionPfizer Laboratories Div Pfizer IncANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-09-258615700260

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