pegademase bovine Injectable Solution

Brand(s)
Adagen
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sigma-Tau Pharmaceuticals, Inc. (2014-12-05)
Oldest Current Product
2010-10-18
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\PEGADEMASE BOVINE
FDAOB
INJECTION\INJECTION\PEGADEMASE BOVINE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\PEGADEMASE BOVINE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\PEGADEMASE BOVINE

product(s) by strength(s)

pegademase bovine 250 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1576650001AdagenNDASigma-Tau Pharmaceuticals, Inc.2010-10-18PEGADEMASE BOVINEINTRAMUSCULARINJECTION, SOLUTIONNDA0198189880b900-ea23-11dc-ad56-0002a5d5c51b

application(s)

#idtitleapplicantapprovedapproved drug
1NDA019818ADAGENSIGMA TAU PHARMACEUTICALS INC1990-03-21NDA019818_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA019818_001RXPEGADEMASE BOVINE (250 UNITS/ML)INJECTIONTrue1990-03-21ADAGEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
19880b900-ea23-11dc-ad56-0002a5d5c51b (view SPL)ADAGEN (pegademase bovine) InjectionprescriptionHuman PrescriptionSigma-Tau Pharmaceuticals, Inc.API MANUFACTURE, MANUFACTURE2014-12-057576650001

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