NDA 202049

CHIESI USA INC

FDA Drug Application

Application #202049

Documents

• Label: 2020-10-30
• Letter: 2020-11-03
• Review: 2021-09-22

Application Sponsors

NDA 202049

CHIESI USA INC

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INHALATION

400MG

2

BRONCHITOL

MANNITOL

FDA Submissions

TYPE 10; Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated

ORIG

1

AP

2020-10-30

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

CHIESI USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202049
            [companyName] => CHIESI USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRONCHITOL","activeIngredients":"MANNITOL","strength":"400MG","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"10\/30\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202049s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202049s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/202049Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-10-30
        )

)