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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 Sigma Tau 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 NDA: 200740

Tradename:
CYSTARAN
Applicant:
Sigma Tau
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 Sigma-Tau Pharmaceuticals, 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, 2015
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Oct 2, 2019
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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