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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Mallinckrodt
Express Scripts
Cerilliant
McKesson
QuintilesIMS
US Department of Justice
Dow
Citi
McKinsey

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091009

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NDA 091009 describes GUAIFENESIN, which is a drug marketed by Actavis Labs Fl, Guardian Pharms, Perrigo R And D, and Aurobindo Pharma Ltd, and is included in six NDAs. It is available from thirty 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-one suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.
Summary for 091009
Tradename:GUAIFENESIN
Applicant:Actavis Labs Fl
Ingredient:guaifenesin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 091009
Suppliers and Packaging for NDA: 091009
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 091009 ANDA L. Perrigo Company 0113-0325 0113-0325-66 1 BOTTLE in 1 CARTON (0113-0325-66) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 091009 ANDA Walgreen Company 0363-0325 0363-0325-30 1 BOTTLE in 1 CARTON (0363-0325-30) > 28 TABLET, EXTENDED RELEASE in 1 BOTTLE

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength1.2GM
Approval Date:Sep 3, 2015TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Cipla
Johnson and Johnson
Cantor Fitzgerald
Novartis
Chinese Patent Office
Cerilliant
Argus Health
QuintilesIMS
Covington

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