ANDA 076699

UCB INC

FDA Drug Application

Application #076699

Documents

• Letter: 2004-08-31
• Review: 2007-04-02

Application Sponsors

ANDA 076699

UCB INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	10MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	PARCOPA	CARBIDOPA; LEVODOPA
002	TABLET, ORALLY DISINTEGRATING;ORAL	25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	PARCOPA	CARBIDOPA; LEVODOPA
003	TABLET, ORALLY DISINTEGRATING;ORAL	25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	PARCOPA	CARBIDOPA; LEVODOPA

FDA Submissions

	ORIG	1	AP	2004-08-27
LABELING; Labeling	SUPPL	4	AP	2010-12-30

Submissions Property Types

SUPPL

4

Null

7

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76699
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PARCOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"10MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PARCOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PARCOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PARCOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"10MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PARCOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PARCOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)