ANDA 091108

SANDOZ INC

FDA Drug Application

Application #091108

Documents

• Letter: 2011-07-29

Application Sponsors

ANDA 091108

SANDOZ INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;INTRAVENOUS	0.002MG/ML (0.002MG/ML)	0	PARICALCITOL	PARICALCITOL
002	SOLUTION;INTRAVENOUS	0.005MG/ML (0.005MG/ML)	0	PARICALCITOL	PARICALCITOL
003	SOLUTION;INTRAVENOUS	0.01MG/2ML (0.005MG/ML)	0	PARICALCITOL	PARICALCITOL

FDA Submissions

ORIG

1

AP

2011-07-27

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91108
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"0.002MG\/ML (0.002MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"0.005MG\/ML (0.005MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"0.01MG\/2ML (0.005MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PARICALCITOL","submission":"PARICALCITOL","actionType":"0.002MG\/ML (0.002MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PARICALCITOL","submission":"PARICALCITOL","actionType":"0.005MG\/ML (0.005MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PARICALCITOL","submission":"PARICALCITOL","actionType":"0.01MG\/2ML (0.005MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)