NDA 020680

ABBOTT

FDA Drug Application

Application #020680

Documents

• Review: 2007-11-19
• Review: 2005-04-27

Application Sponsors

NDA 020680

ABBOTT

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

100MG

0

NORVIR

RITONAVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-03-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-10-01	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1996-09-24	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1997-01-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-07-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-09-12	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1997-10-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-05-21	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1998-02-12	PRIORITY
EFFICACY; Efficacy	SUPPL	11	AP	1999-05-26	PRIORITY
LABELING; Labeling	SUPPL	12	AP	1999-04-29	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1999-04-12	PRIORITY
LABELING; Labeling	SUPPL	14	AP	1999-04-09	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	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
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

ABBOTT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20680
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORVIR","activeIngredients":"RITONAVIR","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NORVIR","submission":"RITONAVIR","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)