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Generated: June 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, 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 091009
Applicant:Actavis Labs Fl
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 N 0113-0325-66
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 091009 ANDA Walgreen Company 0363-0325 N 0363-0325-30

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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