NDA 215868

EXELA PHARMA

FDA Drug Application

Application #215868

Documents

• Letter: 2022-07-21
• Label: 2022-07-22
• Letter: 2023-01-17
• Label: 2023-01-17

Application Sponsors

NDA 215868

EXELA PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	50MG/50ML (1MG/ML)	0	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM
002	SOLUTION;INTRAVENOUS	100MG/100ML (1MG/ML)	0	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-07-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

EXELA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215868
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM IN 0.8% SODIUM CHLORIDE","activeIngredients":"MIDAZOLAM","strength":"50MG\/50ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MIDAZOLAM IN 0.8% SODIUM CHLORIDE","activeIngredients":"MIDAZOLAM","strength":"100MG\/100ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/20\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215868s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/20\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215868s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215868Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-07-20
        )

)