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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 sixteen 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 fifty 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

Tradename:
XYREM
Applicant:
Jazz Pharms
Ingredient:
sodium oxybate
Patents:16
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
XYREM
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:RLD: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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