ANDA 077960

LANNETT CO INC

FDA Drug Application

Application #077960

Documents

• Letter: 2006-10-18

Application Sponsors

ANDA 077960

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

250MG/5ML

0

VALPROIC ACID

VALPROIC ACID

FDA Submissions

	ORIG	1	AP	2006-10-13
LABELING; Labeling	SUPPL	4	AP	2010-01-20
LABELING; Labeling	SUPPL	6	AP	2014-12-15
LABELING; Labeling	SUPPL	9	AP	2014-12-15	STANDARD
LABELING; Labeling	SUPPL	10	AP	2014-12-15	STANDARD
LABELING; Labeling	SUPPL	11	AP	2014-12-15	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-12-15	STANDARD
LABELING; Labeling	SUPPL	13	AP	2014-12-15	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-04-28	STANDARD
LABELING; Labeling	SUPPL	15	AP	2016-04-28	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-04-28	STANDARD
LABELING; Labeling	SUPPL	17	AP	2016-04-28	STANDARD
LABELING; Labeling	SUPPL	18	AP	2016-04-28	STANDARD
LABELING; Labeling	SUPPL	19	AP	2016-04-28	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-10-14	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-10-14	STANDARD
LABELING; Labeling	SUPPL	22	AP	2020-10-14	STANDARD
LABELING; Labeling	SUPPL	24	AP	2020-10-14	STANDARD
LABELING; Labeling	SUPPL	26	AP	2020-10-14	STANDARD

Submissions Property Types

SUPPL	4	Null	7
SUPPL	6	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	15
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	15
SUPPL	22	Null	7
SUPPL	24	Null	15
SUPPL	26	Null	15

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77960
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALPROIC ACID","activeIngredients":"VALPROIC ACID","strength":"250MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VALPROIC ACID","submission":"VALPROIC ACID","actionType":"250MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)