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McKinsey
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Cipla
Accenture
Baxter
Argus Health
Johnson and Johnson
Citi
Teva

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091071

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NDA 091071 describes GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl and Dr Reddys Labs Ltd and is included in two NDAs. It is available from eighteen suppliers. Additional details are available on the GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE 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 091071
Suppliers and Packaging for NDA: 091071
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091071 ANDA L. Perrigo Company 0113-2002 N 0113-2002-68
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091071 ANDA L. Perrigo Company 0113-2002 N 0113-2002-89

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG;60MG
Approval Date:May 27, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength1.2GM;120MG
Approval Date:May 27, 2015TE:RLD:No

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US Department of Justice
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