Application 019039

Type
NDA
Sponsor
PHARMALUCENCE

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45567-0060Kit for the Preparation of Technetium Tc99m PyrophosphateTechnetium Tc99m PyrophosphatePharmalucence, Inc.NDACurrent
45567-0060Kit for the Preparation of Technetium Tc99m PyrophosphateTechnetium Tc99m PyrophosphateSun Pharmaceutical Industries, Inc.NDACurrent
45567-0060Kit for the Preparation of Technetium Tc99m PyrophosphateTechnetium Tc99m PyrophosphatePharmalucence, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82419SUPPL 2025-06-02
82328SUPPL 2025-05-27
1214SUPPL2002-02-27