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Generated: May 23, 2017

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Details for New Drug Application (NDA): 202292

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NDA 202292 describes FULYZAQ, which is a drug marketed by Napo Pharms Inc and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the FULYZAQ profile page.

The generic ingredient in FULYZAQ is crofelemer. Two suppliers are listed for this compound. Additional details are available on the crofelemer profile page.

Summary for NDA: 202292


Pharmacology for NDA: 202292

Suppliers and Packaging for NDA: 202292

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET, DELAYED RELEASE;ORAL 202292 NDA Salix Pharmaceuticals, Inc. 65649-802 65649-802-02 60 TABLET, COATED in 1 BOTTLE (65649-802-02)
TABLET, DELAYED RELEASE;ORAL 202292 NDA Napo Pharmaceuticals, Inc. 70564-802 70564-802-60 60 TABLET, COATED in 1 BOTTLE (70564-802-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength125MG
Approval Date:Dec 31, 2012TE:RLD:Yes
Patent:7,323,195Patent Expiration:Jun 7, 2018Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Dec 31, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:7,341,744Patent Expiration:Jun 16, 2018Product Flag?Substance Flag?Delist Request?

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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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