Documents
Application Sponsors
NDA 212123 | AVID RADIOPHARMS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | INJECTABLE;INJECTION | 370MBQ(10MCI) | 2 | TAUVID | FLORTAUCIPIR F18 |
002 | SOLUTION;INTRAVENOUS | 50ML (8.1-51mCi/ML) | 1 | TAUVID | FLORTAUCIPIR F-18 |
003 | SOLUTION;INTRAVENOUS | 50ML (8.1-100mCi/ML) | 1 | TAUVID | FLORTAUCIPIR F-18 |
004 | SOLUTION;INTRAVENOUS | 100ML (8.1-100mCi/ML) | 1 | TAUVID | FLORTAUCIPIR F-18 |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-05-28 | PRIORITY |
Submissions Property Types
CDER Filings
AVID RADIOPHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212123
[companyName] => AVID RADIOPHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"TAUVID","activeIngredients":"FLORTAUCIPIR F-18","strength":"30ML (8.1-51mCi\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"TAUVID","activeIngredients":"FLORTAUCIPIR F-18","strength":"50ML (8.1-51mCi\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/28\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212123s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212123s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212123Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-05-28
)
)