NDA 204803

DURECT CORP

FDA Drug Application

Application #204803

Documents

• Label: 2021-02-02
• Letter: 2021-02-03
• Review: 2022-05-31
• Letter: 2022-08-04
• Label: 2022-08-05

Application Sponsors

NDA 204803

DURECT CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

132MG/ML

2

POSIMIR

BUPIVACAINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2021-02-01

PRIORITY

Submissions Property Types

ORIG

1

Null

15

CDER Filings

DURECT CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204803
            [companyName] => DURECT CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"POSIMIR","activeIngredients":"BUPIVACAINE","strength":"132MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"02\/01\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204803s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/01\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204803s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-02-01
        )

)