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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209254

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NDA 209254 describes GUAIFENESIN, which is a drug marketed by Actavis Labs Fl, Amneal Pharms, Guardian Drug, Ohm Labs Inc, Perrigo R And D, Aurobindo Pharma Ltd, and Dr Reddys Labs Ltd, and is included in eleven NDAs. It is available from thirty-seven 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 209254
Applicant:Ohm Labs Inc
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 209254

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Jul 16, 2018TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength1.2GM
Approval Date:Jul 16, 2018TE:RLD:No

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