NDA 213645

BAXTER HLTHCARE CORP

FDA Drug Application

Application #213645

Documents

• Label: 2022-01-27
• Letter: 2022-01-27
• Review: 2022-08-23

Application Sponsors

NDA 213645

BAXTER HLTHCARE CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG

0

DAPZURA RT

DAPTOMYCIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-01-25

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213645
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPZURA RT","activeIngredients":"DAPTOMYCIN","strength":"500MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/25\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/213645s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/25\/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\\\/213645s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/213645Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-01-25
        )

)