ANDA 075871

UPSHER SMITH LABS

FDA Drug Application

Application #075871

Application Sponsors

ANDA 075871

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

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 40MG BASE	0	ALENDRONATE SODIUM	ALENDRONATE SODIUM
004	TABLET;ORAL	EQ 35MG BASE	0	ALENDRONATE SODIUM	ALENDRONATE SODIUM
005	TABLET;ORAL	EQ 70MG BASE	0	ALENDRONATE SODIUM	ALENDRONATE SODIUM

FDA Submissions

	ORIG	1	AP	2009-04-22
LABELING; Labeling	SUPPL	2	AP	2016-02-25	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-02-25	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75871
            [companyName] => UPSHER SMITH LABS
            [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 40MG 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 40MG 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
        )

)