NDA 021624

MYLAN INSTITUTIONAL

FDA Drug Application

Application #021624

Documents

• Letter: 2004-02-27
• Review: 2013-06-03
• Label: 2004-03-03
• Letter: 2016-12-20
• Label: 2016-12-21
• Label: 2019-10-08
• Label: 2021-06-03
• Letter: 2021-06-07
• Letter: 2022-05-25
• Label: 2022-06-01

Application Sponsors

NDA 021624

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

1

METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1947-08-13	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2013-06-26
LABELING; Labeling	SUPPL	6	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-06-02	STANDARD
LABELING; Labeling	SUPPL	15	AP	2022-05-24	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	6
SUPPL	10	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	15

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

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(
    [0] => Array
        (
            [ApplNo] => 21624
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021624s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021624s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021624s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021624s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2004","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21624slr001_methadone_hcl_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)