ANDA 090228

INVAGEN PHARMS

FDA Drug Application

Application #090228

Application Sponsors

ANDA 090228

INVAGEN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	10MG;12.5MG	0	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	20MG;12.5MG	0	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	2009-07-09
LABELING; Labeling	SUPPL	2	AP	2015-09-14	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-09-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	9	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90228
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE","activeIngredients":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","strength":"10MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE","activeIngredients":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","strength":"20MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE","submission":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","actionType":"10MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE","submission":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","actionType":"20MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)