MERCK FDA Approval NDA 020506

NDA 020506

MERCK

FDA Drug Application

Application #020506

Application Sponsors

NDA 020506MERCK

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 120MG HYDROCHLORIDE0TIAMATEDILTIAZEM MALATE
002TABLET, EXTENDED RELEASE;ORALEQ 180MG HYDROCHLORIDE0TIAMATEDILTIAZEM MALATE
003TABLET, EXTENDED RELEASE;ORALEQ 240MG HYDROCHLORIDE0TIAMATEDILTIAZEM MALATE

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP1996-10-04STANDARD

Submissions Property Types

ORIG1Null0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20506
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.