FDA.reportPublic FDA data

Application 078242

Type
ANDA
Sponsor
PHARMALUCENCE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TECHNETIUM TC-99M MEBROFENINTECHNETIUM TC-99M MEBROFENIN KITINJECTABLE;INJECTIONN/ANoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45567-0455Kit for the Preparation of Technetium Tc 99m MebrofeninKit for the Preparation of Technetium Tc 99m MebrofeninPharmalucence, Inc.ANDACurrent
45567-0455Kit for the Preparation of Technetium Tc 99m MebrofeninKit for the Preparation of Technetium Tc 99m MebrofeninSun Pharmaceutical Industries, Inc.ANDACurrent
45567-0455Kit for the Preparation of Technetium Tc 99m MebrofeninKit for the Preparation of Technetium Tc 99m MebrofeninPharmalucence, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9135ORIG2008-01-30