NDA 020298

MYLAN INSTITUTIONAL

FDA Drug Application

Application #020298

Documents

• Label: 2016-04-04
• Letter: 2020-09-01
• Label: 2020-09-04
• Letter: 2020-12-21
• Label: 2021-01-08
• Label: 2022-02-18
• Letter: 2022-02-22

Application Sponsors

NDA 020298

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG BASE/VIAL

1

ALOPRIM

ALLOPURINOL SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-05-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-01-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2013-08-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2015-05-13	PRIORITY
LABELING; Labeling	SUPPL	10	AP	2020-08-28	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-02-17	STANDARD
LABELING; Labeling	SUPPL	13	TA	2020-11-05	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	10	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	15

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

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(
    [0] => Array
        (
            [ApplNo] => 20298
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALOPRIM","activeIngredients":"ALLOPURINOL SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/28\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020298s010lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2000","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/020298Orig1s001.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALOPRIM","submission":"ALLOPURINOL SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-08-28
        )

)