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Last Updated: December 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207602

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NDA 207602 describes GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma Ltd, and Perrigo R And D, and is included in four NDAs. It is available from forty-three suppliers. Additional details are available on the GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE profile page.

The generic ingredient in GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Suppliers and Packaging for NDA: 207602
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 207602 ANDA Wyeth Consumer Healthcare LLC 0031-8765 0031-8765-04 1 BLISTER PACK in 1 CARTON (0031-8765-04) > 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 207602 ANDA Wyeth Consumer Healthcare LLC 0031-8765 0031-8765-08 1 BLISTER PACK in 1 CARTON (0031-8765-08) > 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG;1.2GM
Approval Date:Mar 5, 2018TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG;600MG
Approval Date:Mar 5, 2018TE:RLD:No

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