ANDA 091412

DR REDDYS LABS LTD

FDA Drug Application

Application #091412

Application Sponsors

ANDA 091412

DR REDDYS LABS LTD

Marketing Status

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

Application Products

001	CAPSULE;ORAL	1MCG	0	PARICALCITOL	PARICALCITOL
002	CAPSULE;ORAL	2MCG	0	PARICALCITOL	PARICALCITOL
003	CAPSULE;ORAL	4MCG	0	PARICALCITOL	PARICALCITOL

FDA Submissions

ORIG

1

AP

2014-06-24

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91412
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"1MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"2MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"4MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PARICALCITOL","submission":"PARICALCITOL","actionType":"1MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PARICALCITOL","submission":"PARICALCITOL","actionType":"2MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PARICALCITOL","submission":"PARICALCITOL","actionType":"4MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)