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Details for New Drug Application (NDA): 203389
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 five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
The generic ingredient in PROCYSBI is cysteamine bitartrate. There are five 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 |
| Therapeutic Class: | Enzyme Replacements/Modifiers |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203389
| Mechanism of Action | Cystine 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 | N | 49663-001-06 |
| PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389 | NDA | Raptor Therapeutics Inc. | 49663-002 | N | 49663-002-25 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Apr 30, 2013 | TE: | 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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