ANDA 076483

UPSHER SMITH LABS

FDA Drug Application

Application #076483

Application Sponsors

ANDA 076483

UPSHER SMITH LABS

Marketing Status

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

Application Products

001	TABLET;ORAL	10MG	0	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM
002	TABLET;ORAL	20MG	0	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM
003	TABLET;ORAL	40MG	0	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM

FDA Submissions

	ORIG	1	AP	2004-04-23
LABELING; Labeling	SUPPL	7	AP	2013-12-31
LABELING; Labeling	SUPPL	13	AP	2013-12-31	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	13	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76483
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSINOPRIL SODIUM","activeIngredients":"FOSINOPRIL SODIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FOSINOPRIL SODIUM","activeIngredients":"FOSINOPRIL SODIUM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FOSINOPRIL SODIUM","activeIngredients":"FOSINOPRIL SODIUM","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FOSINOPRIL SODIUM","submission":"FOSINOPRIL SODIUM","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FOSINOPRIL SODIUM","submission":"FOSINOPRIL SODIUM","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FOSINOPRIL SODIUM","submission":"FOSINOPRIL SODIUM","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)