NDA 216359

RAFA LABS LTD

FDA Drug Application

Application #216359

Documents

• Label: 2022-08-08
• Letter: 2022-08-09

Application Sponsors

NDA 216359

RAFA LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;AUTOINJECTOR

10MG/0.7ML

0

MIDAZOLAM

MIDAZOLAM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-08-08

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

RAFA LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216359
            [companyName] => RAFA LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM","activeIngredients":"MIDAZOLAM","strength":"10MG\/0.7ML","dosageForm":"INJECTABLE;AUTOINJECTOR","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/08\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216359s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216359s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216359Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-08-08
        )

)