ANDA 090601

HI-TECH PHARMACAL

FDA Drug Application

Application #090601

Application Sponsors

ANDA 090601

HI-TECH PHARMACAL

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2012-02-28
LABELING; Labeling	SUPPL	2	AP	2015-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2015-12-01	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2022-08-05	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-08-05	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-08-05	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	10	Null	15

TE Codes

001

Prescription

AA

CDER Filings

HI-TECH PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90601
            [companyName] => HI-TECH PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"100MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"100MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)