NDA 012003

ABBVIE

FDA Drug Application

Application #012003

Documents

• Letter: 2001-07-23
• Letter: 2001-07-23
• Letter: 2001-07-23
• Letter: 2002-02-04
• Letter: 2001-07-23

Application Sponsors

NDA 012003

ABBVIE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

2MG

0

AKINETON

BIPERIDEN HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1959-09-08	STANDARD
LABELING; Labeling	SUPPL	10	AP	1975-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1975-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1975-09-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1976-01-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1976-06-29	STANDARD
LABELING; Labeling	SUPPL	16	AP	1980-01-30
LABELING; Labeling	SUPPL	18	AP	2001-07-23
LABELING; Labeling	SUPPL	19	AP	2001-07-23
LABELING; Labeling	SUPPL	20	AP	2001-07-23
LABELING; Labeling	SUPPL	21	AP	2001-07-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1987-12-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2000-10-25	STANDARD
LABELING; Labeling	SUPPL	24	AP	2002-02-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2002-05-09	STANDARD

Submissions Property Types

SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12003
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AKINETON","activeIngredients":"BIPERIDEN HYDROCHLORIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AKINETON","submission":"BIPERIDEN HYDROCHLORIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)