Pentostatin Injectable Solution

Brand(s)
Nipent
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-07-31)
Oldest Current Product
2014-08-08
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\PENTOSTATIN
FDAOB
INJECTION\INJECTION\PENTOSTATIN\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PENTOSTATIN
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PENTOSTATIN

product(s) by strength(s)

pentostatin 2 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004090801NipentNDAHospira, Inc.1991-10-11, 2014-08-08PENTOSTATININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA020122151c6d2e-1af1-4c13-96ec-de3228c6efb3, 674e0e6d-46ed-4868-9196-04019d667716

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA077841PENTOSTATINEUROHEALTH INTERNATIONAL SARL2007-08-07ANDA077841_001
2ANDA203554PENTOSTATINMYLAN INSTITUTIONAL LLC2014-09-19ANDA203554_001
3NDA020122NIPENTHOSPIRA INC1991-10-11NDA020122_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA077841_001RXPENTOSTATIN (10MG/VIAL)INJECTIONFalseAP2007-08-07PENTOSTATIN
2ANDA203554_001RXPENTOSTATIN (10MG/VIAL)INJECTIONFalseAP2014-09-19PENTOSTATIN
3NDA020122_001RXPENTOSTATIN (10MG/VIAL)INJECTIONTrueAP1991-10-11NIPENT

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1151c6d2e-1af1-4c13-96ec-de3228c6efb3 (view SPL)NIPENTTM (pentostatin for injection)prescriptionHuman PrescriptionHospira, Inc.2015-07-311004090801
2674e0e6d-46ed-4868-9196-04019d667716 (view SPL)prescriptionHuman PrescriptionHospira, Inc.2015-07-3013004090801

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