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Generated: January 19, 2019

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Details for New Drug Application (NDA): 020576

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NDA 020576 describes CYSTADANE, which is a drug marketed by Orphan Europe and is included in one NDA. It is available from three suppliers. Additional details are available on the CYSTADANE profile page.

The generic ingredient in CYSTADANE is betaine. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the betaine profile page.
Summary for 020576
Applicant:Orphan Europe
Formulation / Manufacturing:see details
Pharmacology for NDA: 020576
Mechanism of ActionMethylating Activity
Suppliers and Packaging for NDA: 020576
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYSTADANE betaine FOR SOLUTION;ORAL 020576 NDA Orphan Europe SARL 52276-400 52276-400-01 180 g in 1 BOTTLE (52276-400-01)
CYSTADANE betaine FOR SOLUTION;ORAL 020576 NDA Ropack Inc. 64811-400 64811-400-01 180 g in 1 BOTTLE (64811-400-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength1GM/SCOOPFUL
Approval Date:Oct 25, 1996TE:RLD:Yes

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