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Serving leading biopharmaceutical companies globally:

US Army
Queensland Health
Harvard Business School
Express Scripts

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200671

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NDA 200671 describes DURLAZA, which is a drug marketed by New Haven Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the DURLAZA profile page.

The generic ingredient in DURLAZA is aspirin. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin profile page.
Summary for 200671
Applicant:New Haven Pharms
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200671
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DURLAZA aspirin CAPSULE, EXTENDED RELEASE;ORAL 200671 NDA New Haven Pharmaceuticals, Inc. 58487-001 E 58487-001-02
DURLAZA aspirin CAPSULE, EXTENDED RELEASE;ORAL 200671 NDA New Haven Pharmaceuticals, Inc. 58487-001 E 58487-001-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength162.5MG
Approval Date:Sep 4, 2015TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Queensland Health
Cantor Fitzgerald

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