TELIGENT PHARMA INC FDA Approval NDA 018933

NDA 018933

TELIGENT PHARMA INC

FDA Drug Application

Application #018933

Application Sponsors

NDA 018933TELIGENT PHARMA INC

Marketing Status

Discontinued002

Application Products

002INJECTABLE;INJECTION100MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;5MCG/VIAL;0.4MG/VIAL;40MG/VIAL;4MG/VIAL;3.6MG/VIAL;3MG/VIAL;1MG/VIAL;10MG/VIAL0M.V.I.-12 LYOPHILIZEDASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE; VITAMIN A; VITAMIN E

CDER Filings

TELIGENT PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18933
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"M.V.I.-12 LYOPHILIZED","activeIngredients":"ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE; VITAMIN A; VITAMIN E","strength":"100MG\/VIAL;0.06MG\/VIAL;0.005MG\/VIAL;15MG\/VIAL;5MCG\/VIAL;0.4MG\/VIAL;40MG\/VIAL;4MG\/VIAL;3.6MG\/VIAL;3MG\/VIAL;1MG\/VIAL;10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"M.V.I.-12 LYOPHILIZED","submission":"ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE; VITAMIN A; VITAMIN E","actionType":"100MG\/VIAL;0.06MG\/VIAL;0.005MG\/VIAL;15MG\/VIAL;5MCG\/VIAL;0.4MG\/VIAL;40MG\/VIAL;4MG\/VIAL;3.6MG\/VIAL;3MG\/VIAL;1MG\/VIAL;10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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