NDA 021486

EMPI

FDA Drug Application

Application #021486

Documents

• Review: 2007-06-04
• Letter: 2004-10-29
• Label: 2004-11-01

Application Sponsors

NDA 021486

EMPI

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;IONTOPHORESIS, TOPICAL

0.01MG/ML;2%

0

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

AP

2004-10-26

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

EMPI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21486
            [companyName] => EMPI
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE","activeIngredients":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","strength":"0.01MG\/ML;2%","dosageForm":"SOLUTION;IONTOPHORESIS, TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/26\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21486lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE","submission":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","actionType":"0.01MG\/ML;2%","submissionClassification":"SOLUTION;IONTOPHORESIS, TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2004-10-26
        )

)