NDA 050697

ABBVIE INC

FDA Drug Application

Application #050697

Documents

• Letter: 2004-07-21

Application Sponsors

NDA 050697

ABBVIE INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	250MG	0	BIAXIN XL	CLARITHROMYCIN
002	TABLET;ORAL	500MG	0	BIAXIN XL	CLARITHROMYCIN

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)	ORIG	1	AP	1993-12-23	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2002-05-24	STANDARD
LABELING; Labeling	SUPPL	3	AP	2004-07-19	STANDARD

Submissions Property Types

ORIG	1	Null	41
SUPPL	3	Null	9

CDER Filings

ABBVIE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50697
            [companyName] => ABBVIE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIAXIN XL","activeIngredients":"CLARITHROMYCIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BIAXIN XL","activeIngredients":"CLARITHROMYCIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BIAXIN XL","submission":"CLARITHROMYCIN","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BIAXIN XL","submission":"CLARITHROMYCIN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)