NDA 021594

INTL MEDICATION SYS

FDA Drug Application

Application #021594

Documents

• Review: 2004-05-06
• Other Important Information from FDA: 2005-07-28
• Letter: 2004-02-27

Application Sponsors

NDA 021594

INTL MEDICATION SYS

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

AMIODARONE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2004-02-04

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

Accessdata Error

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            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)