ANDA 073250

LEADING PHARMA LLC

FDA Drug Application

Application #073250

Application Sponsors

ANDA 073250

LEADING PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

10MG

0

NIFEDIPINE

NIFEDIPINE

FDA Submissions

	ORIG	1	AP	1991-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-07-31
LABELING; Labeling	SUPPL	3	AP	1996-07-26
LABELING; Labeling	SUPPL	4	AP	1997-01-24
LABELING; Labeling	SUPPL	5	AP	1998-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-12-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-06-19
LABELING; Labeling	SUPPL	10	AP	2018-05-21	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	7

TE Codes

001

Prescription

AB

CDER Filings

LEADING PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73250
            [companyName] => LEADING PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIFEDIPINE","activeIngredients":"NIFEDIPINE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NIFEDIPINE","submission":"NIFEDIPINE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)