ANDA 214699

ALKEM LABS LTD

FDA Drug Application

Application #214699

Application Sponsors

ANDA 214699

ALKEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	400MG	0	IBUPROFEN	IBUPROFEN
002	TABLET;ORAL	600MG	0	IBUPROFEN	IBUPROFEN
003	TABLET;ORAL	800MG	0	IBUPROFEN	IBUPROFEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-09-13

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214699
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-13
        )

)