Deferoxamine Injectable Solution

Brand(s)
Desferal
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2012-01-01)
Oldest Current Product
1968-04-02
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\DEFEROXAMINE
FDAOB
INJECTION\INJECTION\DEFEROXAMINE MESYLATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DEFEROXAMINE MESYLATE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DEFEROXAMINE

product(s) by strength(s)

deferoxamine mesylate 213 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780467DesferalNDANovartis Pharmaceuticals Corporation1968-04-02DEFEROXAMINE MESYLATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA016267a7174843-5965-49fc-b842-f7eff7b48bbc

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092336ANDAHospira, Inc.2004-03-17DEFEROXAMINE MESYLATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0760192e87cc7e-8856-4ec6-8c74-0356a352f522, f9ab6b1c-98d0-4373-0e9b-b10cb4a67543
2004092337ANDAHospira, Inc.2004-03-17DEFEROXAMINE MESYLATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0760192e87cc7e-8856-4ec6-8c74-0356a352f522, f9ab6b1c-98d0-4373-0e9b-b10cb4a67543
3633230597ANDAApp Pharmaceuticals, Llc2009-12-15DEFEROXAMINE MESYLATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA078718d91e16df-8daa-4cd2-86a2-273eaa2446e0
4633230599ANDAApp Pharmaceuticals, Llc2009-12-15DEFEROXAMINE MESYLATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA078718d91e16df-8daa-4cd2-86a2-273eaa2446e0

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076019DEFEROXAMINE MESYLATEHOSPIRA INC2004-03-17ANDA076019_001, ANDA076019_002
2ANDA076806DEFEROXAMINE MESYLATETrueWATSON LABORATORIES INC2006-03-31ANDA076806_001, ANDA076806_002
3ANDA078086DEFEROXAMINE MESYLATEEUROHEALTH INTERNATIONAL SARL2007-05-30ANDA078086_001, ANDA078086_002
4ANDA078718DEFEROXAMINE MESYLATEFRESENIUS KABI USA LLC2009-09-15ANDA078718_001, ANDA078718_002
5NDA016267DESFERALNOVARTIS PHARMACEUTICALS CORPNDA016267_001, NDA016267_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076019_001RXDEFEROXAMINE MESYLATE (500MG/VIAL)INJECTIONFalseAP2004-03-17DEFEROXAMINE MESYLATE
2ANDA076019_002RXDEFEROXAMINE MESYLATE (2GM/VIAL)INJECTIONFalseAP2004-03-17DEFEROXAMINE MESYLATE
3ANDA076806_001discontinuedDEFEROXAMINE MESYLATE (500MG/VIAL)INJECTIONFalse2006-03-31DEFEROXAMINE MESYLATE
4ANDA076806_002discontinuedDEFEROXAMINE MESYLATE (2GM/VIAL)INJECTIONFalse2006-03-31DEFEROXAMINE MESYLATE
5ANDA078086_001RXDEFEROXAMINE MESYLATE (500MG/VIAL)INJECTIONFalseAP2007-05-30DEFEROXAMINE MESYLATE
6ANDA078086_002RXDEFEROXAMINE MESYLATE (2GM/VIAL)INJECTIONFalseAP2007-05-30DEFEROXAMINE MESYLATE
7ANDA078718_001RXDEFEROXAMINE MESYLATE (500MG/VIAL)INJECTIONFalseAP2009-09-15DEFEROXAMINE MESYLATE
8ANDA078718_002RXDEFEROXAMINE MESYLATE (2GM/VIAL)INJECTIONFalseAP2009-09-15DEFEROXAMINE MESYLATE
9NDA016267_001RXDEFEROXAMINE MESYLATE (500MG/VIAL)INJECTIONTrueAPDESFERAL
10NDA016267_002RXDEFEROXAMINE MESYLATE (2GM/VIAL)INJECTIONTrueAP2000-05-25DESFERAL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12e87cc7e-8856-4ec6-8c74-0356a352f522 (view SPL)Deferoxamine Mesylate Rx only for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2015-01-0911004092336, 004092337
2a7174843-5965-49fc-b842-f7eff7b48bbc (view SPL)DesferalprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2012-01-017000780467, 000780347
3d91e16df-8daa-4cd2-86a2-273eaa2446e0 (view SPL)Deferoxamine Mesylate for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-04-134633230597, 633230599
4f9ab6b1c-98d0-4373-0e9b-b10cb4a67543 (view SPL)Deferoxamine Rx only Mesylate for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2015-01-0911004092336, 004092337

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