ANDA 062510

ROCHE

FDA Drug Application

Application #062510

Application Sponsors

ANDA 062510

ROCHE

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	0	ROCEPHIN	CEFTRIAXONE SODIUM
002	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	ROCEPHIN	CEFTRIAXONE SODIUM
003	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	ROCEPHIN	CEFTRIAXONE SODIUM

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62510
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROCEPHIN","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ROCEPHIN","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ROCEPHIN","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ROCEPHIN","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 250MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ROCEPHIN","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ROCEPHIN","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)