Drax Exametazime is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Jubilant Draximage Inc., Dba Jubilant Radiopharma. The primary component is Technetium Tc-99m Exametazime.
Product ID | 65174-200_171d8803-5e5a-43ad-b865-4f7ca914151f |
NDC | 65174-200 |
Product Type | Human Prescription Drug |
Proprietary Name | Drax Exametazime |
Generic Name | Kit For The Preparation Of Technetium Tc 99m Exametazime For Leukocyte Labeling |
Dosage Form | Injection, Powder, Lyophilized, For Solution |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2017-08-17 |
Marketing Category | NDA / NDA |
Application Number | NDA208870 |
Labeler Name | Jubilant DraxImage Inc., dba Jubilant Radiopharma |
Substance Name | TECHNETIUM TC-99M EXAMETAZIME |
Active Ingredient Strength | 1 mg/1 |
Pharm Classes | Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2017-08-17 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA208870 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2017-08-17 |
Marketing Category | NDA |
Application Number | NDA208870 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2017-08-17 |
Ingredient | Strength |
---|---|
TECHNETIUM TC-99M EXAMETAZIME | .5 mg/1 |
SPL SET ID: | fa7811f9-2803-4126-8037-8f3e56462f9c |
Manufacturer | |
UNII |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DRAX EXAMETAZIME 87406433 not registered Live/Pending |
Jubilant DraxImage Inc. 2017-04-11 |