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Generated: November 19, 2018

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Details for New Drug Application (NDA): 200740

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NDA 200740 describes CYSTARAN, which is a drug marketed by Leadiant Biosci Inc and is included in one NDA. It is available from one supplier. Additional details are available on the CYSTARAN profile page.

The generic ingredient in CYSTARAN is cysteamine hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cysteamine hydrochloride profile page.
Summary for 200740
Tradename:CYSTARAN
Applicant:Leadiant Biosci Inc
Ingredient:cysteamine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 200740
Generic Entry Date for 200740*:
Constraining patent/regulatory exclusivity:
TREATMENT OF CORNEAL CYSTINE CRYSTAL ACCUMULATION IN PATIENTS WITH CYSTINOSIS
Dosage:
SOLUTION/DROPS;OPHTHALMIC

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 200740
Mechanism of ActionCystine Disulfide Reduction
Suppliers and Packaging for NDA: 200740
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYSTARAN cysteamine hydrochloride SOLUTION/DROPS;OPHTHALMIC 200740 NDA Leadiant Biosciences, Inc. 54482-020 54482-020-01 15 mL in 1 BOTTLE (54482-020-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.44% BASE
Approval Date:Oct 2, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 2, 2019
Regulatory Exclusivity Use:TREATMENT OF CORNEAL CYSTINE CRYSTAL ACCUMULATION IN PATIENTS WITH CYSTINOSIS

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