FDA.reportPublic FDA data

Application 090033

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIFABUTINRIFABUTINCAPSULE;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60687-198rifabutinrifabutinAmerican Health PackagingANDACurrent
60687-198RifabutinRifabutinAmerican Health PackagingANDACurrent
60687-198RifabutinRifabutinAmerican Health PackagingANDACurrent
68180-285rifabutinrifabutinLupin Pharmaceuticals, Inc.ANDACurrent
68180-285rifabutinrifabutinLupin Pharmaceuticals, Inc.ANDACurrent
68180-285rifabutinrifabutinLupin Pharmaceuticals, Inc.ANDACurrent
68180-285rifabutinrifabutinLupin Pharmaceuticals, Inc.ANDACurrent
68180-285rifabutinrifabutinLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9251ORIG2014-02-26