NDA 215252

EXELA PHARMA

FDA Drug Application

Application #215252

Documents

• Letter: 2021-10-29
• Label: 2021-10-29
• Review: 2022-08-04

Application Sponsors

NDA 215252

EXELA PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	125MG/125ML (1MG/ML)	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
002	SOLUTION;INTRAVENOUS	250MG/250ML (1MG/1ML)	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-10-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

EXELA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215252
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"125MG\/125ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"250MG\/250ML (1MG\/1ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/28\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215252s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/28\/2021","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\\\/2021\\\/215252s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215252Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-10-28
        )

)