ANDA 215892

ALEMBIC PHARMS LTD

FDA Drug Application

Application #215892

Application Sponsors

ANDA 215892

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	25MG	0	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE
002	CAPSULE;ORAL	50MG	0	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-10

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] => 215892
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/10\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-10
        )

)