NDA 012418

ABBVIE

FDA Drug Application

Application #012418

Documents

• Letter: 2001-07-23
• Letter: 2001-07-23
• Letter: 2001-07-23
• Letter: 2001-07-23

Application Sponsors

NDA 012418

ABBVIE

Marketing Status

• Discontinued: 002

Application Products

002

INJECTABLE;INJECTION

5MG/ML

0

AKINETON

BIPERIDEN LACTATE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1961-04-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1976-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1979-10-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	2001-07-23	STANDARD
LABELING; Labeling	SUPPL	7	AP	2001-07-23	STANDARD
LABELING; Labeling	SUPPL	8	AP	2001-07-23	STANDARD
LABELING; Labeling	SUPPL	9	AP	2001-07-23	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12418
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AKINETON","activeIngredients":"BIPERIDEN LACTATE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AKINETON","submission":"BIPERIDEN LACTATE","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)