ANDA 077304

EXELA PHARMA SCS LLC

FDA Drug Application

Application #077304

Documents

• Letter: 2006-09-25

Application Sponsors

ANDA 077304

EXELA PHARMA SCS LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

0

CAFFEINE CITRATE

CAFFEINE CITRATE

FDA Submissions

ORIG

1

AP

2006-09-21

TE Codes

001

Prescription

AA

CDER Filings

EXELA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77304
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAFFEINE CITRATE","activeIngredients":"CAFFEINE CITRATE","strength":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CAFFEINE CITRATE","submission":"CAFFEINE CITRATE","actionType":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)