BLA 761071

SANDOZ INC

FDA Drug Application

Application #761071

Documents

• Label: 2018-10-31
• Letter: 2019-02-28
• Medication Guide: 2018-11-09
• Review: 2019-03-21
• Letter: 2021-02-25
• Label: 2021-02-26
• Medication Guide: 2021-02-26
• Letter: 2022-03-29
• Label: 2022-03-29
• Medication Guide: 2022-03-29
• Letter: 2022-07-19
• Letter: 2022-07-19
• Label: 2022-07-20
• Label: 2022-07-20
• Medication Guide: 2022-07-20

Application Sponsors

BLA 761071

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

40MG/0.8ML

0

HYRIMOZ

ADALIMUMAB-ADAZ

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2018-10-30	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2022-07-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2022-03-28	N/A
EFFICACY; Efficacy	SUPPL	12	AP	2022-07-18	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	10	Null	6
SUPPL	12	Null	7

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761071
            [companyName] => SANDOZ INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/761071lbl.pdf#page=36"]
            [products] => [{"drugName":"HYRIMOZ","activeIngredients":"ADALIMUMAB-ADAZ","strength":"40MG\/0.8ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/30\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761071lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761071lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761071Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761071Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-10-30
        )

)