Rifabutin Oral Capsule

Brand(s)
Mycobutin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Greenstone Llc (2015-08-12)
Oldest Current Product
1995-03-15
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\RIFABUTIN
FDAOB
ORAL\CAPSULE\RIFABUTIN
SPL Active
ORAL\CAPSULE\RIFABUTIN
SPL Moiety
ORAL\CAPSULE\RIFABUTIN

product(s) by strength(s)

rifabutin 150 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597621350NDAGreenstone Llc2014-04-07RIFABUTINORALCAPSULENDA050689c2026b67-4755-4236-96b6-a6b5e7399707

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1681800285ANDALupin Pharmaceuticals, Inc.2014-03-26RIFABUTINORALCAPSULEANDA0900334be9cc3f-0016-4426-a700-574b45ce245b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548682841MycobutinNDAPhysicians Total Care, Inc.1995-03-15RIFABUTINORALCAPSULE00013530117NDA050689b8351a60-1000-4656-90ae-1fa666030dd4

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA090033RIFABUTINLUPIN LTD2014-02-24ANDA090033_001
2NDA050689MYCOBUTINPHARMACIA AND UPJOHN CO1992-12-23NDA050689_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA090033_001RXRIFABUTIN (150MG)ORALCAPSULEFalseAB2014-02-24RIFABUTIN
2NDA050689_001RXRIFABUTIN (150MG)ORALCAPSULETrueAB1992-12-23MYCOBUTIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13e1a6613-bdd3-4261-93b3-d7f5cc09064b (view SPL)Mycobutin (Rifabutin) Capsules, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-08-0412000135301
24be9cc3f-0016-4426-a700-574b45ce245b (view SPL)Rifabutin Capsules USP, 150 mg Rx onlyprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.manufacture2015-10-013681800285
3b8351a60-1000-4656-90ae-1fa666030dd4 (view SPL)Mycobutin rifabutin capsules, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-041548682841
4c2026b67-4755-4236-96b6-a6b5e7399707 (view SPL)Rifabutin capsules, USPprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-08-123597621350

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