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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo
Cantor Fitzgerald
US Department of Justice

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078912

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NDA 078912 describes GUAIFENESIN, which is a drug marketed by Actavis Labs Fl, Guardian Pharms, Perrigo R And D, Aurobindo Pharma Ltd, and Dr Reddys Labs Ltd, and is included in eight NDAs. It is available from twenty-nine suppliers. Additional details are available on the GUAIFENESIN profile page.

The generic ingredient in GUAIFENESIN is guaifenesin; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.
Summary for 078912
Applicant:Perrigo R And D
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078912
Suppliers and Packaging for NDA: 078912
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 078912 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7712 N 0615-7712-39
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 078912 ANDA American Sales Company 41520-652 N 41520-652-39

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Nov 23, 2011TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
US Army

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