Cystine Depleting Agent Drug Class List
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Drugs in Drug Class: Cystine Depleting Agent
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare | CYSTADROPS | cysteamine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 211302-001 | Aug 19, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | CYSTAGON | cysteamine bitartrate | CAPSULE;ORAL | 020392-002 | Aug 15, 1994 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | CYSTAGON | cysteamine bitartrate | CAPSULE;ORAL | 020392-001 | Aug 15, 1994 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Leadiant Biosci Inc | CYSTARAN | cysteamine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 200740-001 | Oct 2, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon | PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389-001 | Apr 30, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Horizon | PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389-002 | Apr 30, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Horizon | PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389-001 | Apr 30, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
