Documents
Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 6MG/0.6ML | 0 | NYVEPRIA | PEGFILGRASTIM-APGF |
FDA Submissions
| TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | AP | 2020-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-04-16 | STANDARD |
Submissions Property Types
CDER Filings
HOSPIRA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 761111
[companyName] => HOSPIRA INC
[docInserts] => ["",""]
[products] => [{"drugName":"NYVEPRIA","activeIngredients":"PEGFILGRASTIM-APGF","strength":"6MG\/0.6ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/10\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761111lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761111lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761111Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-06-10
)
)