NDA 017116

SPECGX LLC

FDA Drug Application

Application #017116

Documents

• Letter: 2005-05-27
• Label: 2005-05-27
• Letter: 2002-03-27
• Letter: 2005-05-27
• Letter: 2005-08-08
• Letter: 2005-08-08
• Letter: 2008-02-07
• Other Important Information from FDA: 2006-11-27
• Label: 2005-05-27
• Label: 2008-02-14
• Letter: 2017-01-03
• Label: 2016-12-21
• Label: 2018-02-01
• Letter: 2018-02-02
• Label: 2019-10-08
• Letter: 2019-10-08
• Letter: 2021-06-03
• Label: 2021-06-03
• Label: 2021-09-13
• Letter: 2021-09-21
• Label: 2021-12-09

Application Sponsors

NDA 017116

SPECGX LLC

Marketing Status

• Prescription: 002

Application Products

002

CONCENTRATE;ORAL

10MG/ML

1

METHADOSE

METHADONE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1973-03-14	STANDARD
LABELING; Labeling	SUPPL	2	AP	1977-02-11
LABELING; Labeling	SUPPL	7	AP	1980-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1980-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1981-11-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-09-07	STANDARD
LABELING; Labeling	SUPPL	12	AP	1993-04-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-03-27	STANDARD
LABELING; Labeling	SUPPL	15	AP	2005-05-26	STANDARD
LABELING; Labeling	SUPPL	16	AP	2005-05-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2005-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2005-08-03	STANDARD
LABELING; Labeling	SUPPL	21	AP	2008-02-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2014-06-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2014-09-22	STANDARD
LABELING; Labeling	SUPPL	29	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	32	AP	2018-02-01	STANDARD
LABELING; Labeling	SUPPL	38	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	41	AP	2021-06-02	STANDARD
LABELING; Labeling	SUPPL	43	AP	2021-09-13	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	15
SUPPL	32	Null	6
SUPPL	38	Null	6
SUPPL	41	Null	7
SUPPL	43	Null	7

TE Codes

002

Prescription

AA

CDER Filings

SPECGX LLC

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(
    [0] => Array
        (
            [ApplNo] => 17116
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADOSE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/017116s038lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2018","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/017116s032lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017116s029lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-29","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017116s029lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017116s029lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2008","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/017116s021lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2005","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/017116s015,016lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2005","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/017116s015,016lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"METHADOSE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG\/ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)