Documents
Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 100MG | 0 | NEXVIAZYME | AVALGLUCOSIDASE ALFA-NGPT |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2021-08-06 | PRIORITY |
Submissions Property Types
CDER Filings
GENZYME CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 761194
[companyName] => GENZYME CORP
[docInserts] => ["",""]
[products] => [{"drugName":"NEXVIAZYME","activeIngredients":"AVALGLUCOSIDASE ALFA-NGPT","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"08\/06\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761194s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/06\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761194s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761194Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-08-06
)
)