NDA 214770

MERCK SHARP DOHME

FDA Drug Application

Application #214770

Documents

• Label: 2021-05-31
• Letter: 2021-06-03
• Review: 2021-11-22
• Label: 2022-01-14
• Letter: 2022-01-18
• Label: 2022-01-21
• Letter: 2022-01-21

Application Sponsors

NDA 214770

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION, DELAYED RELEASE;ORAL

0

NOXAFIL POWDERMIX

POSACONAZOLE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2021-05-31	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	15

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214770
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"NOXAFIL POWDERMIX","activeIngredients":"POSACONAZOLE","strength":"","dosageForm":"SUSPENSION, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/31\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214770s000,205053s012,205596s012lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/31\/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\\\/214770s000,205053s012,205596s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-05-31
        )

)