Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | 100MG/10ML(10MG/ML) | 0 | RUXIENCE | RITUXIMAB-PVVR |
002 | INJECTABLE;INJECTION | 500MG/50ML(10MG/ML) | 0 | RUXIENCE | RITUXIMAB-PVVR |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2019-07-23 | STANDARD |
EFFICACY; Efficacy | SUPPL | 3 | AP | 2020-05-26 | STANDARD |
EFFICACY; Efficacy | SUPPL | 5 | AP | 2021-11-15 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 23 |
SUPPL | 3 | Null | 15 |
SUPPL | 5 | Null | 7 |
CDER Filings
PFIZER INC
cder:Array
(
[0] => Array
(
[ApplNo] => 761103
[companyName] => PFIZER INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761103s003lbl.pdf#page=32"]
[products] => [{"drugName":"RUXIENCE","activeIngredients":"RITUXIMAB-PVVR","strength":"100MG\/10ML(10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RUXIENCE","activeIngredients":"RITUXIMAB-PVVR","strength":"500MG\/50ML(10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"05\/26\/2020","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761103s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761103s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761103s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761103Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761103Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"05\/26\/2020","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761103s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761103Orig1s003ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-05-26
)
)