ANDA 216048

CIPLA LTD

FDA Drug Application

Application #216048

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 216048

CIPLA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SPRAY;NASAL

5MG

0

MIDAZOLAM

MIDAZOLAM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-11-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

CIPLA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216048
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM","activeIngredients":"MIDAZOLAM","strength":"5MG","dosageForm":"SPRAY;NASAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/01\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-01
        )

)