Indexing - product concept
-     
Food and Drug Administration
Reference Label Set Id: ff4941b3-9901-4aab-adcf-c5327bede34e

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Application Product Concept
  kit
Product Information
Product Type INDEXING - PRODUCT CONCEPT Item Code (Source) 3bb2a06a-64e7-1380-e8d7-189718b04a63
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 10 mL
Part 2 50 mL
Part 1 of 2
  injection
Product Information
Item Code (Source) be4be4ef-3629-2cac-c011-02ea955a7950
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM NITRITE (UNII: M0KG633D4F) (NITRITE ION - UNII:J39976L608) SODIUM NITRITE 30 mg  in 1 mL
Part 2 of 2
  injection
Product Information
Item Code (Source) 06879002-6dea-3c2f-71c1-614568bd0e06
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM THIOSULFATE (UNII: HX1032V43M) (THIOSULFATE ION - UNII:LLT6XV39PY) SODIUM THIOSULFATE 250 mg  in 1 mL
Application Product Concept
Product Information
Product Type INDEXING - PRODUCT CONCEPT Item Code (Source) d106808e-3051-96a1-aaa3-e4504dd8b3d6
Marketing Information
Marketing Category Application Number or Monograph Citation
NDA NDA201444
Labeler - Food and Drug Administration (927645523)

Revised: 12/2017
Document Id: 099e2235-0666-4e5a-b518-18c86aeb644d
Set id: 4073022c-5d5d-48f5-82ed-091ad146a4b2
Version: 1
Effective Time: 20171211
 
Food and Drug Administration