ANDA 040189

JUBILANT CADISTA

FDA Drug Application

Application #040189

Application Sponsors

ANDA 040189

JUBILANT CADISTA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	4MG	0	METHYLPREDNISOLONE	METHYLPREDNISOLONE
002	TABLET;ORAL	8MG	0	METHYLPREDNISOLONE	METHYLPREDNISOLONE
003	TABLET;ORAL	16MG	0	METHYLPREDNISOLONE	METHYLPREDNISOLONE
004	TABLET;ORAL	32MG	0	METHYLPREDNISOLONE	METHYLPREDNISOLONE

FDA Submissions

	ORIG	1	AP	1997-10-31
LABELING; Labeling	SUPPL	2	AP	1998-03-19
LABELING; Labeling	SUPPL	4	AP	2002-09-05
LABELING; Labeling	SUPPL	5	AP	2002-09-05
LABELING; Labeling	SUPPL	6	AP	2003-07-14
LABELING; Labeling	SUPPL	10	AP	2007-07-19

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	1

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

JUBILANT CADISTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40189
            [companyName] => JUBILANT CADISTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"16MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"32MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLPREDNISOLONE","submission":"METHYLPREDNISOLONE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPREDNISOLONE","submission":"METHYLPREDNISOLONE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPREDNISOLONE","submission":"METHYLPREDNISOLONE","actionType":"16MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPREDNISOLONE","submission":"METHYLPREDNISOLONE","actionType":"32MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)