ANDA 078454

APOTEX INC

FDA Drug Application

Application #078454

Documents

• Other Important Information from FDA: 2008-07-01

Application Sponsors

ANDA 078454

APOTEX INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	7.5MG	0	MOEXIPRIL HYDROCHLORIDE	MOEXIPRIL HYDROCHLORIDE
002	TABLET;ORAL	15MG	0	MOEXIPRIL HYDROCHLORIDE	MOEXIPRIL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-06-02
LABELING; Labeling	SUPPL	2	AP	2015-03-02	STANDARD

Submissions Property Types

SUPPL

2

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78454
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MOEXIPRIL HYDROCHLORIDE","activeIngredients":"MOEXIPRIL HYDROCHLORIDE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MOEXIPRIL HYDROCHLORIDE","activeIngredients":"MOEXIPRIL HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MOEXIPRIL HYDROCHLORIDE","submission":"MOEXIPRIL HYDROCHLORIDE","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MOEXIPRIL HYDROCHLORIDE","submission":"MOEXIPRIL HYDROCHLORIDE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)