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Generated: April 28, 2017

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Details for New Drug Application (NDA): 021196

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NDA 021196 describes XYREM, which is a drug marketed by Jazz Pharms and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XYREM profile page.

The generic ingredient in XYREM is sodium oxybate. There are one thousand three hundred and seventy-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium oxybate profile page.

Summary for NDA: 021196

Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021196

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sodium oxybate
SOLUTION;ORAL 021196 NDA Jazz Pharmaceuticals, Inc. 68727-100 68727-100-01 1 BOTTLE, PLASTIC in 1 CARTON (68727-100-01) > 180 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength500MG/ML
Approval Date:Jul 17, 2002TE:AARLD:Yes
Patent:6,780,889Patent Expiration:Jul 4, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:7,262,219Patent Expiration:Jul 4, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:8,859,619Patent Expiration:Dec 22, 2019Product Flag?YSubstance Flag?Delist Request?

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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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