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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203284


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NDA 203284 describes RAVICTI, which is a drug marketed by Horizon Therap Us and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the RAVICTI profile page.

The generic ingredient in RAVICTI is glycerol phenylbutyrate. There are fifty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the glycerol phenylbutyrate profile page.
Summary for 203284
Tradename:RAVICTI
Applicant:Horizon Therap Us
Ingredient:glycerol phenylbutyrate
Patents:15
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 203284
Suppliers and Packaging for NDA: 203284
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284 NDA Horizon Therapeutics USA, Inc. 75987-050 75987-050-06 1 BOTTLE in 1 CARTON (75987-050-06) / 25 mL in 1 BOTTLE
RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284 NDA Horizon Therapeutics USA, Inc. 75987-050 75987-050-07 4 BOTTLE in 1 CARTON (75987-050-07) / 25 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;ORALStrength1.1GM/ML
Approval Date:Feb 1, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 28, 2024
Regulatory Exclusivity Use:FOR USE AS A NITROGEN-BINDING AGENT FOR CHRONIC MANAGEMENT OF PEDIATRIC PATIENTS >=2 MONTHS AND < 2 YEARS OF AGE WITH UREA CYCLE DISORDERS (UCDS) WHO CANNOT BE MANAGED BY DIETARY PROTEIN RESTRICTION AND/OR AMINO ACID SUPPLEMENTATION ALONE
Patent:⤷  Try a TrialPatent Expiration:Sep 22, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF A UREA CYCLE DISORDER
Patent:⤷  Try a TrialPatent Expiration:Sep 22, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF A UREA CYCLE DISORDER

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