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CYSTADANE (nda020576)- (1GM/SCOOPFUL)

BETAINE RECORDATI RARE
1GM/SCOOPFUL
No No
Expired Expired
None None
None No
CYSTADANE is a methylating agent indicated in pediatric and adult patients for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations. Included within the category of homocystinuria are: • Cystathionine beta-synthase (CBS) deficiency • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency • Cobalamin cofactor metabolism (cbl) defect.
2 0 2
Total Other Developers None
Drugs with Suitability No
1GM/SCOOPFUL ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 2
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Expired
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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