Documents
Application Sponsors
Marketing Status
Application Products
001 | ELIXIR;ORAL | 0.05MG/ML | 0 | DIGOXIN | DIGOXIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-10-04 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
VISTAPHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 213000
[companyName] => VISTAPHARM
[docInserts] => ["",""]
[products] => [{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.05MG\/ML","dosageForm":"ELIXIR;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/213000Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-10-04
)
)