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Serving leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Novartis
Express Scripts
Covington
Mallinckrodt
Colorcon
Queensland Health
Dow
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Generated: November 18, 2017

DrugPatentWatch Database Preview

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 two suppliers. Additional details are available on the CYSTADANE profile page.

The generic ingredient in CYSTADANE is betaine hydrochloride. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the betaine hydrochloride profile page.

Summary for 020576

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020576

Mechanism of ActionMethylating Activity

Medical Subject Heading (MeSH) Categories for 020576

Suppliers and Packaging for NDA: 020576

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYSTADANE
betaine hydrochloride
FOR SOLUTION;ORAL 020576 NDA Orphan Europe SARL 52276-400 52276-400-01 180 g in 1 BOTTLE (52276-400-01)
CYSTADANE
betaine hydrochloride
FOR SOLUTION;ORAL 020576 NDA Rare Disease Therapeutics, Inc. 66621-4000 66621-4000-1 180 POWDER, FOR SOLUTION in 1 BOTTLE (66621-4000-1)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Covington
Merck
UBS
Farmers Insurance
Colorcon
Mallinckrodt
Moodys
Federal Trade Commission
Baxter
Harvard Business School

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