ANDA 090906

LOTUS PHARM CO LTD

FDA Drug Application

Application #090906

Documents

• Letter: 2021-12-20

Application Sponsors

ANDA 090906

LOTUS PHARM CO LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	500MG	0	LEVETIRACETAM	LEVETIRACETAM
002	TABLET;ORAL	250MG	0	LEVETIRACETAM	LEVETIRACETAM
003	TABLET;ORAL	750MG	0	LEVETIRACETAM	LEVETIRACETAM
004	TABLET;ORAL	1GM	0	LEVETIRACETAM	LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2010-11-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2016-10-31
LABELING; Labeling	SUPPL	5	AP	2015-01-16	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-11-24	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-12-26	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

LOTUS PHARM CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90906
            [companyName] => LOTUS PHARM CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)