Melphalan Injectable Solution

Brand(s)
Alkeran
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Apo-Pharma Usa, Inc (2012-02-15)
Oldest Current Product
2009-10-27
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\MELPHALAN
FDAOB
INJECTION\INJECTION\MELPHALAN HYDROCHLORIDE\rdfq

product(s) by strength(s)

melphalan 5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1526093001AlkeranNDAApo-Pharma Usa, Inc2011-01-01NDA0202079706e9a1-96ab-46b8-8846-32ee9d756b1d

generic product(s)(s)

#idcategorylabelerfirst marketedapplicationspl
1674570195ANDAMylan Institutional Llc2013-01-10ANDA090270a8bf1877-fd06-4ef6-b82d-fe0ff1956bde
2674570215ANDAMylan Institutional Llc2013-01-10ANDA090270a8bf1877-fd06-4ef6-b82d-fe0ff1956bde
3674570579ANDAMylan Institutional Llc2014-09-29ANDA0902707349a5f7-0b8d-4055-98b2-3b4b2629dd1f

invalid application product(s)

#idcategorylabelerfirst marketedapplicationspl
1101390321ANDAGeneramedix Inc.2009-10-27ANDA090299e77d77f3-3e96-4ff3-a42d-8bd67dfcf58b

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA090270MELPHALAN HYDROCHLORIDEMYLAN INSTITUTIONAL LLC2009-06-09ANDA090270_001
2ANDA090299MELPHALAN HYDROCHLORIDETrueMYLAN INSTITUTIONAL LLC2009-10-27ANDA090299_001
3ANDA090303MELPHALAN HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2010-10-28ANDA090303_001
4NDA020207ALKERANGLAXOSMITHKLINE1992-11-18NDA020207_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA090270_001RXMELPHALAN HYDROCHLORIDE (EQ 50MG BASE/VIAL)INJECTIONFalseAP2009-06-09MELPHALAN HYDROCHLORIDE
2ANDA090299_001discontinuedMELPHALAN HYDROCHLORIDE (EQ 50MG BASE/VIAL)INJECTIONFalse2009-10-27MELPHALAN HYDROCHLORIDE
3ANDA090303_001RXMELPHALAN HYDROCHLORIDE (EQ 50MG BASE/VIAL)INJECTIONFalseAP2010-10-28MELPHALAN HYDROCHLORIDE
4NDA020207_001RXMELPHALAN HYDROCHLORIDE (EQ 50MG BASE/VIAL)INJECTIONTrueAP1992-11-18ALKERAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17349a5f7-0b8d-4055-98b2-3b4b2629dd1f (view SPL)Melphalan Hydrochloride for InjectionprescriptionHuman PrescriptionMylan Institutional Llc2012-08-011674570579
29706e9a1-96ab-46b8-8846-32ee9d756b1d (view SPL)ALKERAN (melphalan hydrochloride) for InjectionprescriptionHuman PrescriptionApo-Pharma Usa, Inc2012-02-156526093001
3a8bf1877-fd06-4ef6-b82d-fe0ff1956bde (view SPL)Melphalan Hydrochloride for InjectionprescriptionHuman PrescriptionMylan Institutional Llc2012-08-316674570195, 674570215
4e77d77f3-3e96-4ff3-a42d-8bd67dfcf58b (view SPL)prescriptionHuman PrescriptionGeneramedix Inc.manufacture2009-10-272101390321

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