ANDA 210341

ALEMBIC PHARMS LTD

FDA Drug Application

Application #210341

Application Sponsors

ANDA 210341

ALEMBIC PHARMS LTD

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

UNKNOWN;

ORIG

1

AP

2019-06-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210341
            [companyName] => ALEMBIC PHARMS LTD
            [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":"06\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-05
        )

)