Application 016042

Type: NDA
Sponsor: GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DYAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	CAPSULE;ORAL	25MG;50MG	No	No
003	DYAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	CAPSULE;ORAL	25MG;37.5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016042-002	DYAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982
N016042-003	DYAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016042-002	DYAZIDE	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016042-003	DYAZIDE	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016042-002	DYAZIDE	25MG;50MG	CAPSULE / ORAL		Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016042-003	DYAZIDE	25MG;37.5MG	CAPSULE / ORAL		RLD	1994-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016042-002	DYAZIDE	25MG;50MG	CAPSULE / ORAL		Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016042-003	DYAZIDE	25MG;37.5MG	CAPSULE / ORAL		RLD	1994-03-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016042-002	DYAZIDE	25MG;50MG	CAPSULE / ORAL		Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016042-003	DYAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RLD, RS	1994-03-03	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N016042-003	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N016042-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016042-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016042-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016042-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016042-003	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0007-3650	DYAZIDE	hydrochlorothiazide and triamterene	GlaxoSmithKline LLC	NDA	Current
0007-3650	DYAZIDE	hydrochlorothiazide and triamterene	GlaxoSmithKline LLC	NDA	Current
0007-3650	DYAZIDE	hydrochlorothiazide and triamterene	GlaxoSmithKline LLC	NDA	Current
0007-3650	DYAZIDE	hydrochlorothiazide and triamterene	GlaxoSmithKline LLC	NDA	Current
0007-3650	DYAZIDE	hydrochlorothiazide and triamterene	GlaxoSmithKline LLC	NDA	Current
55154-4510	DYAZIDE	hydrochlorothiazide and triamterene	Cardinal Health	NDA	Current
65084-135	DYAZIDE	hydrochlorothiazide and triamterene	Mckesson Rxpak Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64434	SUPPL	2020-08-27
64349	SUPPL	2020-08-21
33141	SUPPL	2011-03-21
12967	SUPPL	2011-03-17
33140	SUPPL	2010-03-03
12966	SUPPL	2010-02-26
412	SUPPL	2007-05-29