ANDA 210459

ALEMBIC PHARMS LTD

FDA Drug Application

Application #210459

Application Sponsors

ANDA 210459

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-31

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210459
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/31\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-31
        )

)