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Generated: October 18, 2018

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Details for New Drug Application (NDA): 203389

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NDA 203389 describes PROCYSBI, which is a drug marketed by Horizon Pharma Usa and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug. Additional details are available on the PROCYSBI profile page.

The generic ingredient in PROCYSBI is cysteamine bitartrate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
Summary for 203389
Tradename:PROCYSBI
Applicant:Horizon Pharma Usa
Ingredient:cysteamine bitartrate
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 203389
Mechanism of ActionCystine Disulfide Reduction
Suppliers and Packaging for NDA: 203389
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389 NDA Raptor Therapeutics Inc. 49663-001 49663-001-06 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (49663-001-06)
PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389 NDA Raptor Therapeutics Inc. 49663-002 49663-002-25 250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (49663-002-25)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 25MG BASE
Approval Date:Apr 30, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 30, 2020
Regulatory Exclusivity Use:MANAGEMENT OF NEPHROPATHIC CYSTINOSIS IN ADULTS AND CHILDREN AGES 6 YEARS AND OLDER.
Regulatory Exclusivity Expiration:Aug 14, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Feb 14, 2023
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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US Department of Justice
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Dow
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