BLA 761103

PFIZER INC

FDA Drug Application

Application #761103

Documents

• Label: 2019-07-23
• Medication Guide: 2019-07-23
• Letter: 2019-08-20
• Review: 2019-08-20
• Label: 2020-05-27
• Medication Guide: 2020-05-27
• Letter: 2020-05-29
• Label: 2021-11-16
• Medication Guide: 2021-11-16
• Letter: 2021-11-17

Application Sponsors

BLA 761103

PFIZER INC

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
        )

)