Lomustine Oral Capsule

Brand(s)
CeeNU, Gleostine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Nextsource Biotechnology, Llc (2015-11-05)
Oldest Current Product
2014-07-29
License(s)
NDA
RxNORM
ORAL CAPSULE\LOMUSTINE
FDAOB
ORAL\CAPSULE\LOMUSTINE
SPL Active
ORAL\CAPSULE, GELATIN COATED\LOMUSTINE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\LOMUSTINE

product(s) by strength(s)

lomustine 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1581813030NDANextsource Biotechnology, Llc2014-07-29LOMUSTINEORALCAPSULE, GELATIN COATEDNDA017588d8fc55b8-e0d9-48ac-bc9f-350f49007d0a
2581813040GleostineNDANextsource Biotechnology, Llc2014-08-18LOMUSTINEORALCAPSULE, GELATIN COATEDNDA0175887f77526b-4c40-409c-82ea-d0f934d89cc2

lomustine 100 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1581813032NDANextsource Biotechnology, Llc2014-07-29LOMUSTINEORALCAPSULE, GELATIN COATEDNDA017588d8fc55b8-e0d9-48ac-bc9f-350f49007d0a

lomustine 40 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1581813031NDANextsource Biotechnology, Llc2014-07-29LOMUSTINEORALCAPSULE, GELATIN COATEDNDA017588d8fc55b8-e0d9-48ac-bc9f-350f49007d0a
2581813041GleostineNDANextsource Biotechnology, Llc2014-08-18LOMUSTINEORALCAPSULE, GELATIN COATEDNDA0175887f77526b-4c40-409c-82ea-d0f934d89cc2

lomustine 5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1581813043GleostineNDANextsource Biotechnology, Llc2015-11-05LOMUSTINEORALCAPSULE, GELATIN COATEDNDA0175887f77526b-4c40-409c-82ea-d0f934d89cc2

application(s)

#idtitleapplicantapproved drug
1NDA017588GLEOSTINECORDEN PHARMA LATINA SPANDA017588_001, NDA017588_002, NDA017588_003, NDA017588_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA017588_001RXLOMUSTINE (10MG)ORALCAPSULEFalseGLEOSTINE
2NDA017588_002RXLOMUSTINE (40MG)ORALCAPSULEFalseGLEOSTINE
3NDA017588_003RXLOMUSTINE (100MG)ORALCAPSULETrueGLEOSTINE
4NDA017588_004RXLOMUSTINE (5MG)ORALCAPSULEFalse2014-12-19GLEOSTINE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
117893de9-7d54-448c-9fca-d10642046d14 (view SPL)CeeNU (lomustine)CapsulesprescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2012-11-218000153030, 000153031, 000153032
27f77526b-4c40-409c-82ea-d0f934d89cc2 (view SPL)GleostineTM (lomustine) CapsulesprescriptionHuman PrescriptionNextsource Biotechnology, Llc2015-11-056581813040, 581813041, 581813043, 581813042
3d8fc55b8-e0d9-48ac-bc9f-350f49007d0a (view SPL)prescriptionHuman PrescriptionNextsource Biotechnology, Llc2013-08-086581813030, 581813031, 581813032

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