Documents
Application Sponsors
Marketing Status
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
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
)
)