Application 074701

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	CAPSULE;ORAL	25MG;37.5MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	CAPSULE / ORAL			1996-06-07

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	1996-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074701-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL		1996-06-07	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074701-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074701-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074701-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074701-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074701-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074701-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074701-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074701-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074701-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074701-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074701-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074701-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074701-001	AB	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	5ee165a3-39a4-4d12-aff2-a6fb3309ce39	2026-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	7dc3414b-dcb5-4b11-bca7-c0fa3f474aea	2026-09-03	Boxed warning, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Sandoz Inc	f824b6ba-bd1c-41a8-8f6f-ad507b48f3e0	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	f083c321-3170-4982-b5cd-d3fdff754857	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	4bc374e2-8650-41bc-8ce6-92062661bf8a	2026-07-01	Boxed warning, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	0de72197-607f-ef0a-e063-6394a90a8949	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	03b11335-2e88-2f7b-e063-6394a90afe2a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	43425ec7-a2c0-41d8-b759-b7b5918949ce	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	St. Mary's Medical Park Pharmacy	de5e7c85-5bf5-5b5f-e053-2995a90a1fba	2026-06-01	Boxed warning, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	f3bc491a-961d-4a38-8a55-c4a03be05b74	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	e7c34985-a8be-45d3-9273-2b13e2f6b7b2	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	bdd4348d-928d-ef0b-e053-2a95a90aadb4	2026-02-20	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Apotex Corp.	bd6c3495-ec70-908b-482a-a979506659e9	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Golden State Medical Supply, Inc.	9fe534cd-cf5f-64b4-e053-2995a90a926e	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	6c4cd90b-44c0-4da5-8f26-f0fa465acce4	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Advagen Pharma Ltd	a5525a2a-d2c7-411b-9ffc-0cc4fe77f7c7	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f32b8809-80e9-18f2-e053-2995a90a5428	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	9ec3d35f-b25d-48f4-926f-f093e402ccde	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	db895e64-3f97-9201-e053-2a95a90ac7ef	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	08f3885e-dfde-79e4-e063-6394a90a4c09	2025-12-26	Boxed warning, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2537	Triamterene and Hydrochlorothiazide	triamterene and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2537	Triamterene and Hydrochlorothiazide	triamterene and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2537	Triamterene and Hydrochlorothiazide	triamterene and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-1333	Triamterene and Hydrochlorothiazide	triamterene and hydrochlorothiazide	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
49999-066	Triamterene and Hydrochlorothiazide	triamterene and hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
51079-935	Triamterene and Hydrochlorothiazide	triamterene and hydrochlorothiazide	Mylan Institutional Inc.	ANDA	Current
51079-935	Triamterene and Hydrochlorothiazide	triamterene and hydrochlorothiazide	Mylan Institutional Inc.	ANDA	Current
71335-1039	Triamterene and Hydrochlorothiazide	triamterene and hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-1039	Triamterene and Hydrochlorothiazide	triamterene and hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current