Flucytosine Oral Capsule

Brand(s)
Ancobon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Valeant Pharmaceuticals North America Llc (2013-11-05)
Oldest Current Product
1971-11-26
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\FLUCYTOSINE
FDAOB
ORAL\CAPSULE\FLUCYTOSINE
SPL Active
ORAL\CAPSULE\FLUCYTOSINE
SPL Moiety
ORAL\CAPSULE\FLUCYTOSINE

product(s) by strength(s)

flucytosine 250 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001873554AncobonNDAValeant Pharmaceuticals North America Llc1971-11-26FLUCYTOSINEORALCAPSULENDA017001aea0df00-a88c-4a16-abcf-750f3ff2004e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1649800179ANDARising Pharmaceuticals, Inc.2011-07-15FLUCYTOSINEORALCAPSULEANDA20156658189ec7-118b-458a-8e4f-7867a97cfcbd

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1681510084ANDACarilion Materials Management2011-07-15FLUCYTOSINEORALCAPSULE649800179ANDA20156659f0bf8c-21a8-4932-85b2-2fe017a2a486
2691890267ANDAAvera Mckennan Hospital2015-03-01FLUCYTOSINEORALCAPSULE649800179ANDA20156663973195-5e24-4962-92b8-0727ac0244d4

flucytosine 500 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001873555AncobonNDAValeant Pharmaceuticals North America Llc1971-11-26FLUCYTOSINEORALCAPSULENDA017001aea0df00-a88c-4a16-abcf-750f3ff2004e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1649800180ANDARising Pharmaceuticals, Inc.2011-07-15FLUCYTOSINEORALCAPSULEANDA20156658189ec7-118b-458a-8e4f-7867a97cfcbd

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551546575AncobonNDACardinal Health1982-01-01FLUCYTOSINEORALCAPSULE001873555NDA017001820e2477-e247-4349-86fc-144c4a6a289c

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA201566FLUCYTOSINESIGMAPHARM LABORATORIES LLC2011-06-28ANDA201566_001, ANDA201566_002
2NDA017001ANCOBONVALEANT PHARMACEUTICALS INTERNATIONALNDA017001_001, NDA017001_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA201566_001RXFLUCYTOSINE (250MG)ORALCAPSULEFalseAB2011-06-28FLUCYTOSINE
2ANDA201566_002RXFLUCYTOSINE (500MG)ORALCAPSULEFalseAB2011-06-28FLUCYTOSINE
3NDA017001_001RXFLUCYTOSINE (250MG)ORALCAPSULEFalseABANCOBON
4NDA017001_002RXFLUCYTOSINE (500MG)ORALCAPSULETrueABANCOBON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
158189ec7-118b-458a-8e4f-7867a97cfcbd (view SPL)FLUCYTOSINE CAPSULES, USP RX onlyprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.manufacture2011-08-182649800179, 649800180
259f0bf8c-21a8-4932-85b2-2fe017a2a486 (view SPL)FLUCYTOSINE CAPSULES, USP RX onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-08-182681510084
363973195-5e24-4962-92b8-0727ac0244d4 (view SPL)FLUCYTOSINE CAPSULES, USP RX onlyprescriptionHuman PrescriptionAvera Mckennan Hospitalrelabel, repack2015-11-131691890267
4820e2477-e247-4349-86fc-144c4a6a289c (view SPL)ANCOBON (flucytosine)CAPSULESprescriptionHuman PrescriptionCardinal HealthREPACK2012-05-143551546575
5aea0df00-a88c-4a16-abcf-750f3ff2004e (view SPL)ANCOBON (flucytosine)CAPSULESprescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2013-11-053001873554, 001873555

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