NDA 016042

GLAXOSMITHKLINE LLC

FDA Drug Application

Application #016042

Documents

• Letter: 2007-05-29
• Letter: 2010-02-26
• Letter: 2011-03-17
• Label: 2010-03-03
• Label: 2011-03-21
• Letter: 2020-08-21
• Label: 2020-08-27

Application Sponsors

NDA 016042

GLAXOSMITHKLINE LLC

Marketing Status

• Discontinued: 002
• Prescription: 003

Application Products

002	CAPSULE;ORAL	25MG;50MG	0	DYAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE
003	CAPSULE;ORAL	25MG;37.5MG	1	DYAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1965-12-02	STANDARD
REMS; REMS	SUPPL	8	AP	1976-06-23	STANDARD
REMS; REMS	SUPPL	14	AP	1976-01-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1975-02-27	STANDARD
LABELING; Labeling	SUPPL	17	AP	1975-02-27
LABELING; Labeling	SUPPL	18	AP	1976-06-23
LABELING; Labeling	SUPPL	19	AP	1975-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1976-01-27	STANDARD
LABELING; Labeling	SUPPL	23	AP	1976-05-21
LABELING; Labeling	SUPPL	24	AP	1976-05-21
LABELING; Labeling	SUPPL	25	AP	1976-11-03
LABELING; Labeling	SUPPL	26	AP	1977-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1977-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1977-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1977-06-14	STANDARD
LABELING; Labeling	SUPPL	30	AP	1978-02-22
LABELING; Labeling	SUPPL	31	AP	1978-02-22
LABELING; Labeling	SUPPL	32	AP	1978-02-22
LABELING; Labeling	SUPPL	33	AP	1978-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1978-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1978-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1978-01-19	STANDARD
LABELING; Labeling	SUPPL	37	AP	1979-09-18
LABELING; Labeling	SUPPL	38	AP	1979-09-18
LABELING; Labeling	SUPPL	39	AP	1979-09-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1981-02-02	STANDARD
LABELING; Labeling	SUPPL	41	AP	1979-12-06
LABELING; Labeling	SUPPL	43	AP	1980-01-14
LABELING; Labeling	SUPPL	44	AP	1981-01-27
LABELING; Labeling	SUPPL	45	AP	1980-07-14
LABELING; Labeling	SUPPL	46	AP	1982-02-23
LABELING; Labeling	SUPPL	47	AP	1988-04-26
LABELING; Labeling	SUPPL	48	AP	1981-10-30
LABELING; Labeling	SUPPL	49	AP	1982-08-25
LABELING; Labeling	SUPPL	51	AP	1982-10-08
LABELING; Labeling	SUPPL	52	AP	1985-01-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1983-05-13	STANDARD
EFFICACY; Efficacy	SUPPL	55	AP	1994-03-03	UNKNOWN
LABELING; Labeling	SUPPL	56	AP	1985-03-07
LABELING; Labeling	SUPPL	57	AP	1986-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1988-02-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	1991-12-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1992-05-01	STANDARD
LABELING; Labeling	SUPPL	64	AP	1994-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	1994-05-20	STANDARD
LABELING; Labeling	SUPPL	66	AP	1994-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	1998-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	1999-03-16	STANDARD
LABELING; Labeling	SUPPL	69	AP	2001-02-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	2000-12-20	STANDARD
LABELING; Labeling	SUPPL	74	AP	2007-05-18	STANDARD
LABELING; Labeling	SUPPL	77	AP	2010-02-23	UNKNOWN
LABELING; Labeling	SUPPL	78	AP	2011-03-15	UNKNOWN
LABELING; Labeling	SUPPL	79	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	21	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	40	Null	0
SUPPL	54	Null	0
SUPPL	59	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	65	Null	0
SUPPL	67	Null	0
SUPPL	68	Null	0
SUPPL	70	Null	0
SUPPL	77	Null	6
SUPPL	78	Null	6
SUPPL	79	Null	6

TE Codes

003

Prescription

AB

CDER Filings

GLAXOSMITHKLINE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16042
            [companyName] => GLAXOSMITHKLINE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DYAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","strength":"25MG;50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DYAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","strength":"25MG;37.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/20\/2020","submission":"SUPPL-79","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/016042s079lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2011","submission":"SUPPL-78","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/016042s078lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2010","submission":"SUPPL-77","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/016042s077lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DYAZIDE","submission":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","actionType":"25MG;50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DYAZIDE","submission":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","actionType":"25MG;37.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-08-20
        )

)