bsp; RDT C PI003
Cystadane
betaine powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66621-4000
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
betaine (betaine) betaine 6 g
Product Characteristics
Color white (none) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
Item Code Package Description
1 NDC:66621-4000-1 180 POWDER, FOR SOLUTION (SCOOPFUL) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020576 10/25/1996
Labeler - Rare Disease Therapeutics, Inc. (966133100)
Registrant - Rare Disease Therapeutics, Inc. (966133100)
Establishment
Name Address ID/FEI Operations
Rare Disease Therapeutics, Inc. 966133100 label
Establishment
Name Address ID/FEI Operations
Orphan Europe, SARL 767598352 manufacture
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