Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 100MG/4ML | 0 | ZIRABEV | BEVACIZUMAB-BVZR |
| 002 | INJECTABLE;INJECTION | 400MG/16ML | 0 | ZIRABEV | BEVACIZUMAB-BVZR |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2019-06-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2021-02-09 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-02-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 7 |
CDER Filings
PFIZER INC
cder:Array
(
[0] => Array
(
[ApplNo] => 761099
[companyName] => PFIZER INC
[docInserts] => ["",""]
[products] => [{"drugName":"ZIRABEV","activeIngredients":"BEVACIZUMAB-BVZR","strength":"100MG\/4ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ZIRABEV","activeIngredients":"BEVACIZUMAB-BVZR","strength":"400MG\/16ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/27\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761099s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/27\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761099s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761099Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761099Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2019-06-27
)
)