Details for New Drug Application (NDA): 021196
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The generic ingredient in XYREM is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.
Summary for 021196
Tradename: | XYREM |
Applicant: | Jazz Pharms |
Ingredient: | sodium oxybate |
Patents: | 6 |
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 AUTHORIZED GENERIC | Hikma Pharmaceuticals USA Inc. | 0054-9628 | 0054-9628-57 | 180 mL in 1 BOTTLE, PLASTIC (0054-9628-57) |
XYREM | sodium oxybate | SOLUTION;ORAL | 021196 | NDA | Jazz Pharmaceuticals, Inc. | 68727-100 | 68727-100-01 | 180 mL in 1 BOTTLE, PLASTIC (68727-100-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 0.5GM/ML | ||||
Approval Date: | Jul 17, 2002 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Oct 26, 2025 | ||||||||
Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY | ||||||||
Regulatory Exclusivity Expiration: | Apr 26, 2026 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 15, 2033 | Product Flag? | Substance Flag? | Delist Request? | Y |
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