ANDA 078684

BRECKENRIDGE

FDA Drug Application

Application #078684

Application Sponsors

ANDA 078684

BRECKENRIDGE

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

EQ 15MG BASE/ML

0

RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2009-08-27

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78684
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 15MG BASE\/ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RANITIDINE HYDROCHLORIDE","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 15MG BASE\/ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)