NDA 209511

INNOCOLL PHARMACEUTICALS

FDA Drug Application

Application #209511

Documents

• Letter: 2020-09-01
• Label: 2020-09-02
• Review: 2021-07-22

Application Sponsors

NDA 209511

INNOCOLL PHARMACEUTICALS

Marketing Status

• Prescription: 001

Application Products

001

IMPLANT;SUBCUTANEOUS

300MG

0

XARACOLL

BUPIVACAINE HCI

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination

ORIG

1

AP

2020-08-28

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

INNOCOLL PHARMACEUTICALS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209511
            [companyName] => INNOCOLL PHARMACEUTICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"XARACOLL","activeIngredients":"BUPIVACAINE HCI","strength":"300MG","dosageForm":"IMPLANT;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209511Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-28
        )

)