Application 018124

Type
NDA
Sponsor
PHARMALUCENCE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIS-MDPTECHNETIUM TC-99M MEDRONATE KITINJECTABLE;INJECTIONN/ANoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45567-0040Kit for the Preparation of Technetium Tc 99M MedronateTC 99M MEDRONATEPharmalucence, Inc.NDACurrent
45567-0040Kit for the Preparation of Technetium Tc 99M MedronateTC 99M MEDRONATEPharmalucence, Inc.NDACurrent
45567-0040Kit for the Preparation of Technetium Tc 99M MedronateTC 99M MEDRONATESun Pharmaceutical Industries, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82418SUPPL 2025-06-02
82327SUPPL 2025-05-27
33438SUPPL2005-04-28
14916SUPPL2005-04-28