BLA 761081

PFIZER INC

FDA Drug Application

Application #761081

Documents

• Label: 2019-03-11
• Letter: 2019-03-12
• Review: 2019-05-17
• Letter: 2020-01-28
• Letter: 2020-05-08

Application Sponsors

BLA 761081

PFIZER INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

420MG

0

TRAZIMERA

TRASTUZUMAB-QYYP

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-03-11	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-01-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-05-07	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	6	Null	15

CDER Filings

PFIZER INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761081
            [companyName] => PFIZER INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAZIMERA","activeIngredients":"TRASTUZUMAB-QYYP","strength":"420MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/11\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761081s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761081s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761081Orig1s000Approv.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761081Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/07\/2020","submission":"SUPPL-6","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761081Orig1s006ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"01\/24\/2020","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761081Orig1s002ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-07
        )

)