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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020576

CYSTADANE (BETAINE)
1GM/SCOOPFUL
Marketing Status: Prescription
Active Ingredient: BETAINE
Proprietary Name: CYSTADANE
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: 1GM/SCOOPFUL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020576
Product Number: 001
Approval Date: Oct 25, 1996
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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