Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 15, 2019

DrugPatentWatch Database Preview

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
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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