FDA.reportPublic FDA data

Application 017858

Type
NDA
Sponsor
PHARMALUCENCE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AN-SULFUR COLLOIDTECHNETIUM TC-99M SULFUR COLLOID KITSOLUTION;INJECTION, ORALN/AYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45567-0030Kit for the Prepartion of Technetium Tc99m Sulfur ColloidTechnetium Tc 99m Sulfur ColloidSun Pharmaceutical Industries, Inc.NDACurrent
45567-0030Kit for the Prepartion of Technetium Tc99m Sulfur ColloidTechnetium Tc 99m Sulfur ColloidPharmalucence Inc.NDACurrent
45567-0030Kit for the Prepartion of Technetium Tc99m Sulfur ColloidTechnetium Tc 99m Sulfur ColloidPharmalucence Inc.NDACurrent
45567-0030Kit for the Prepartion of Technetium Tc99m Sulfur ColloidTechnetium Tc 99m Sulfur ColloidPharmalucence Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61409SUPPL2019-12-23
61366SUPPL2019-12-20
20094SUPPL2012-09-12
725SUPPL2012-08-16
11081SUPPL2012-08-15
11080SUPPL2011-07-27
13932SUPPL2011-07-26
724SUPPL2002-09-13