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Details for New Drug Application (NDA): 091070

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NDA 091070 describes GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Actavis Labs Fl Inc and is included in one NDA. It is available from twenty-one 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-two drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.

Summary for NDA: 091070

Suppliers and Packaging for NDA: 091070

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 091070 ANDA Walgreen Company 0363-0735 0363-0735-30 1 BOTTLE in 1 CARTON (0363-0735-30) > 28 TABLET, EXTENDED RELEASE in 1 BOTTLE
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL 091070 ANDA Walgreen Company 0363-0735 0363-0735-55 1 BOTTLE in 1 CARTON (0363-0735-55) > 42 TABLET, EXTENDED RELEASE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG;600MG
Approval Date:Aug 31, 2015TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG;1.2GM
Approval Date:Aug 31, 2015TE:RLD:No


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