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Serving leading biopharmaceutical companies globally:

Teva
Deloitte
Chubb
Fuji
Cipla
Baxter
Federal Trade Commission
QuintilesIMS
Cerilliant
Colorcon

Generated: December 15, 2017

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 five 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:1
Applicant:1
Ingredient:1
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)

Summary 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:ORPHAN DRUG EXCLUSIVITY


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Cipla
McKinsey
Teva
US Department of Justice
Covington
Accenture
Deloitte
Express Scripts

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