ANDA 090557

JUBILANT CADISTA

FDA Drug Application

Application #090557

Application Sponsors

ANDA 090557

JUBILANT CADISTA

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	ALENDRONATE SODIUM	ALENDRONATE SODIUM
002	TABLET;ORAL	EQ 10MG BASE	0	ALENDRONATE SODIUM	ALENDRONATE SODIUM
003	TABLET;ORAL	EQ 35MG BASE	0	ALENDRONATE SODIUM	ALENDRONATE SODIUM
004	TABLET;ORAL	EQ 70MG BASE	0	ALENDRONATE SODIUM	ALENDRONATE SODIUM

FDA Submissions

	ORIG	1	AP	2010-02-18
LABELING; Labeling	SUPPL	2	AP	2012-12-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-09-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-09-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-10-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7

TE Codes

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

CDER Filings

JUBILANT CADISTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90557
            [companyName] => JUBILANT CADISTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALENDRONATE SODIUM","activeIngredients":"ALENDRONATE SODIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ALENDRONATE SODIUM","activeIngredients":"ALENDRONATE SODIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ALENDRONATE SODIUM","activeIngredients":"ALENDRONATE SODIUM","strength":"EQ 35MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ALENDRONATE SODIUM","activeIngredients":"ALENDRONATE SODIUM","strength":"EQ 70MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALENDRONATE SODIUM","submission":"ALENDRONATE SODIUM","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ALENDRONATE SODIUM","submission":"ALENDRONATE SODIUM","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ALENDRONATE SODIUM","submission":"ALENDRONATE SODIUM","actionType":"EQ 35MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ALENDRONATE SODIUM","submission":"ALENDRONATE SODIUM","actionType":"EQ 70MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)