FDA.reportPublic FDA data

Application 050689

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCOBUTINRIFABUTINCAPSULE;ORAL150MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0013-5301MycobutinrifabutinPharmacia and Upjohn Company LLCNDACurrent
0013-5301MycobutinrifabutinPfizer Laboratories Div Pfizer IncNDACurrent
0013-5301MycobutinrifabutinPfizer Laboratories Div Pfizer IncNDACurrent
0013-5301MycobutinrifabutinPharmacia and Upjohn Company LLCNDACurrent
0013-5301MycobutinrifabutinPfizer Laboratories Div Pfizer IncNDACurrent
0013-5301MycobutinrifabutinPharmacia and Upjohn Company LLCNDACurrent
55695-010MycobutinrifabutinDepartment of State Health Services, Pharmacy BranchNDACurrent
59762-1350RifabutinrifabutinGreenstone LLCNDACurrent
59762-1350RifabutinrifabutinGreenstone LLCNDACurrent
59762-1350RifabutinrifabutinGreenstone LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80265SUPPL 2024-11-21
80249SUPPL 2024-11-20
68643SUPPL2021-09-20
68635SUPPL2021-09-17
66703SUPPL2021-03-09
66661SUPPL2021-03-09
8014SUPPL2015-07-09
39122SUPPL2015-07-06
39121SUPPL2014-12-02
30286SUPPL2014-11-14
18028SUPPL2008-06-05
30285SUPPL2008-05-14
39120SUPPL2003-05-07
30284SUPPL2001-11-09
8013SUPPL2001-11-09