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Details for New Drug Application (NDA): 018685

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NDA 018685 describes GAVISCON, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. Additional details are available on the GAVISCON profile page.

The generic ingredient in GAVISCON is aluminum hydroxide; magnesium trisilicate. There are one hundred and nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aluminum hydroxide; magnesium trisilicate profile page.

Summary for NDA: 018685

Sanofi Aventis Us
aluminum hydroxide; magnesium trisilicate
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 018685

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
aluminum hydroxide; magnesium trisilicate
TABLET, CHEWABLE;ORAL 018685 NDA GlaxoSmithKline Consumer Healthcare LP 0135-0096 0135-0096-26 100 TABLET, CHEWABLE in 1 BOTTLE (0135-0096-26)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength80MG;20MG
Approval Date:Dec 9, 1983TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength160MG;40MG
Approval Date:Dec 9, 1983TE:RLD:Yes

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