metreleptin Injectable Solution

Brand(s)
Myalept
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amylin Pharmaceuticals, Llc (2014-06-30)
Oldest Current Product
2014-05-22
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\METRELEPTIN
SPL Active
SUBCUTANEOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\METRELEPTIN
SPL Moiety
SUBCUTANEOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\METRELEPTIN

product(s) by strength(s)

metreleptin 5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1667800310MyaleptBLAAmylin Pharmaceuticals, Llc2014-05-22METRELEPTINSUBCUTANEOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION125390b6349e72-8bbb-40c6-ab31-89f7b1cce914

application(s)

#idtitleapprovedtradenamesfda division
1125390metreleptin Application2014-02-24MyaleptCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1b6349e72-8bbb-40c6-ab31-89f7b1cce914 (view SPL)These highlights do not include all the information needed to use MYALEPT safely and effectively. See full prescribing information for MYALEPT. MYALEPT (metreleptin) for injection for subcutaneous use Initial U.S. Approval: 2014prescriptionHuman PrescriptionAmylin Pharmaceuticals, Llc2014-06-303667800310
2c986f93b-855d-4ef0-b620-5d41a0513e48 (view SPL)These highlights do not include all the information needed to use MYALEPT safely and effectively. See full prescribing information for MYALEPT. MYALEPT (metreleptin) for injection for subcutaneous use Initial U.S. Approval: 2014prescriptionHuman PrescriptionAegerion Pharmaceuticals, Inc.2015-09-014764310210

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