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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 206941


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NDA 206941 describes GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Perrigo R And D, and Sun Pharm, and is included in six NDAs. It is available from fifty-nine 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. Sixty-three suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Suppliers and Packaging for NDA: 206941
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 206941 ANDA WALGREEN CO. 0363-0474 0363-0474-01 4 BLISTER PACK in 1 CARTON (0363-0474-01) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 206941 ANDA WALGREEN CO. 0363-0474 0363-0474-67 2 BLISTER PACK in 1 CARTON (0363-0474-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG;600MG
Approval Date:Mar 17, 2017TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG;1.2GM
Approval Date:Mar 17, 2017TE:RLD:No

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