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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
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Fish and Richardson
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Generated: September 26, 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 NDA: 020576

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
betaine hydrochloride
FOR SOLUTION;ORAL 020576 NDA Orphan Europe SARL 52276-400 52276-400-01 180 g in 1 BOTTLE (52276-400-01)
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 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Johnson and Johnson
US Department of Justice
Cantor Fitzgerald
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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