ANDA 040362

JUBILANT CADISTA

FDA Drug Application

Application #040362

Documents

• Letter: 2001-08-29

Application Sponsors

ANDA 040362

JUBILANT CADISTA

Marketing Status

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

Application Products

001	TABLET;ORAL	10MG	0	PREDNISONE	PREDNISONE
002	TABLET;ORAL	5MG	0	PREDNISONE	PREDNISONE
003	TABLET;ORAL	20MG	0	PREDNISONE	PREDNISONE

FDA Submissions

	ORIG	1	AP	2001-08-29
LABELING; Labeling	SUPPL	2	AP	2004-05-11
S; Supplement	SUPPL	3	AP	2005-06-29
LABELING; Labeling	SUPPL	4	AP	2005-06-29

Submissions Property Types

SUPPL

3

Null

0

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

JUBILANT CADISTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40362
            [companyName] => JUBILANT CADISTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREDNISONE","submission":"PREDNISONE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PREDNISONE","submission":"PREDNISONE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PREDNISONE","submission":"PREDNISONE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)