Documents
Application Sponsors
ANDA 208521 | MAIA PHARMS INC | |
Marketing Status
Application Products
001 | SOLUTION;INTRAVENOUS | 10%;10% (5GM/50ML;5GM/50ML) | 0 | SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM BENZOATE; SODIUM PHENYLACETATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-05-08 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
MAIA PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208521
[companyName] => MAIA PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"SODIUM PHENYLACETATE AND SODIUM BENZOATE","activeIngredients":"SODIUM BENZOATE; SODIUM PHENYLACETATE","strength":"10%;10% (5GM\/50ML;5GM\/50ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/08\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208521Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-05-08
)
)