Application Sponsors
ANDA 213648 | SOLARIS PHARMA CORP | |
Marketing Status
Application Products
001 | GEL;VAGINAL | 0.75% | 0 | METRONIDAZOLE | METRONIDAZOLE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-10-14 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
SOLARIS PHARMA CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 213648
[companyName] => SOLARIS PHARMA CORP
[docInserts] => ["",""]
[products] => [{"drugName":"METRONIDAZOLE","activeIngredients":"METRONIDAZOLE","strength":"0.75%","dosageForm":"GEL;VAGINAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-10-14
)
)