ANDA 040903

LEADING PHARMA LLC

FDA Drug Application

Application #040903

Documents

• Label: 2013-10-04

Application Sponsors

ANDA 040903

LEADING PHARMA LLC

Marketing Status

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

Application Products

001	TABLET;ORAL	10MG	0	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE
002	TABLET;ORAL	25MG	0	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE
003	TABLET;ORAL	50MG	0	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2012-10-24
LABELING; Labeling	SUPPL	4	AP	2014-11-17	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	4	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

LEADING PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40903
            [companyName] => LEADING PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMIPRAMINE HYDROCHLORIDE","activeIngredients":"IMIPRAMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IMIPRAMINE HYDROCHLORIDE","activeIngredients":"IMIPRAMINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IMIPRAMINE HYDROCHLORIDE","activeIngredients":"IMIPRAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/24\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/040903lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IMIPRAMINE HYDROCHLORIDE","submission":"IMIPRAMINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IMIPRAMINE HYDROCHLORIDE","submission":"IMIPRAMINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IMIPRAMINE HYDROCHLORIDE","submission":"IMIPRAMINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-10-24
        )

)