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Generated: May 30, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 1 |
| Therapeutic Class: | Enzyme Replacements/Modifiers |
| Formulation / Manufacturing: | see details |
| Mechanism of Action | Cystine Disulfide Reduction |
| 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) |
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Apr 30, 2013 | TE: | RLD: | Yes | |||||
| Patent: | 9,173,851 | Patent Expiration: | Jun 17, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,233,077 | Patent Expiration: | Jun 17, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,026,284 | Patent Expiration: | Sep 22, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES | ||||||||
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