ANDA 211890

ALKEM LABS LTD

FDA Drug Application

Application #211890

Documents

• Letter: 2021-09-02

Application Sponsors

ANDA 211890

ALKEM LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

800MG; 26.6MG

0

IBUPROFEN AND FAMOTIDINE

IBUPROFEN; FAMOTIDINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-12-23

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211890
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/23\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-23
        )

)