ANDA 202060

BRECKENRIDGE

FDA Drug Application

Application #202060

Application Sponsors

ANDA 202060

BRECKENRIDGE

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

0

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2017-03-08

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202060
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE","activeIngredients":"POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"420GM\/BOT;1.48GM\/BOT;5.72GM\/BOT;11.2GM\/BOT","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/08\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-08
        )

)