ANDA 076521

IMPAX LABS

FDA Drug Application

Application #076521

Application Sponsors

ANDA 076521

IMPAX LABS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	25MG;100MG	0	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA
002	TABLET, EXTENDED RELEASE;ORAL	50MG;200MG	0	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA

FDA Submissions

	ORIG	1	AP	2004-05-14
LABELING; Labeling	SUPPL	4	AP	2010-10-06
LABELING; Labeling	SUPPL	11	AP	2022-11-21	STANDARD

Submissions Property Types

SUPPL	4	Null	7
SUPPL	11	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76521
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"50MG;200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBIDOPA AND LEVODOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"25MG;100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARBIDOPA AND LEVODOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"50MG;200MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)