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Generated: May 26, 2017

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Details for New Drug Application (NDA): 010679

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NDA 010679 describes CANTIL, 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 CANTIL profile page.

The generic ingredient in CANTIL is mepenzolate bromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the mepenzolate bromide profile page.

Summary for NDA: 010679

Therapeutic Class:Gastrointestinal Agents

Pharmacology for NDA: 010679

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 010679

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
mepenzolate bromide
SOLUTION;ORAL 010679 NDA sanofi-aventis U.S. LLC 0068-0037 0068-0037-01 100 TABLET in 1 BOTTLE (0068-0037-01)
mepenzolate bromide
TABLET;ORAL 010679 NDA sanofi-aventis U.S. LLC 0068-0037 0068-0037-01 100 TABLET in 1 BOTTLE (0068-0037-01)

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength25MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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