Amifostine Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bedford Laboratories (2013-05-31)
Oldest Current Product
2008-03-14
License(s)
NDA, ANDA
RxNORM
INJECTION\AMIFOSTINE
FDAOB
INJECTION\INJECTION\AMIFOSTINE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AMIFOSTINE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AMIFOSTINE
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AMIFOSTINE ANHYDROUS
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AMIFOSTINE: AMIFOSTINE ANHYDROUS

product(s) by strength(s)

amifostine 500 mg injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1553900308NDABedford Laboratories2008-04-02AMIFOSTINEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA0202210a47114c-569c-40be-afd8-a22d2e99bb5d

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1473350581ANDASun Pharma Global Fze2008-03-14AMIFOSTINEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA077126db42eca3-274a-43d3-a0be-e5209747bedc
2627560581ANDASun Pharmaceutical Industries Limited2008-03-14AMIFOSTINEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0771264cd49351-6dde-4c85-be33-9a20bde785db

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA077126AMIFOSTINESUN PHARMA GLOBAL INC2008-03-14ANDA077126_001
2NDA020221ETHYOLCLINIGEN HEALTHCARE LTD1995-12-08p5994409, METHODS FOR USING THE DRUG PRODUCTNDA020221_001, NDA020221_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA077126_001RXAMIFOSTINE (500MG/VIAL)INJECTIONFalseAP2008-03-14AMIFOSTINE
2NDA020221_001RXAMIFOSTINE (500MG/VIAL)INJECTIONTrueAP1995-12-08ETHYOL
3NDA020221_002discontinuedAMIFOSTINE (375MG/VIAL)INJECTIONFalse1999-09-10ETHYOL

patent(s)

#idexpiration dateapplication(s)
1p5994409 (view patent)2017-12-08NDA020221

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10a47114c-569c-40be-afd8-a22d2e99bb5d (view SPL)AMIFOSTINE FOR INJECTIONprescriptionHuman PrescriptionBedford Laboratories2013-05-318553900308
24cd49351-6dde-4c85-be33-9a20bde785db (view SPL)Amifostine for InjectionprescriptionHuman PrescriptionSun Pharmaceutical Industries Limitedanalysis, manufacture2009-11-141627560581
3db42eca3-274a-43d3-a0be-e5209747bedc (view SPL)Amifostine for Injection USPprescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2015-05-112473350581

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