Application 074857

Type: ANDA
Sponsor: NOVARTIS

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
A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	CAPSULE / ORAL			1997-09-09

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074857-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	1997-09-09	`f41ea6bd6efb…`

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 2 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	Chartwell RX, LLC	261dd83f-8048-488f-8b71-c4abd9692720	2025-12-10	Adverse reactions	Name fallback brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	e505484d-b600-4d13-a4b9-278dc4a2e73a	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	860bed38-26f2-49bb-9dba-8928cec3c42c	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	02752dae-30b7-4726-b22b-985b330a2060	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	1fff8245-2b65-4ab1-aaa2-6bbbc6ac5fe8	2025-10-01	Boxed warning, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	5fc69fbf-c2d2-41ef-99bb-62a76ef74db2	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	BluePoint Laboratories	4f44fb73-7f61-4623-ae89-61abd8e945ab	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5ba2c08b-5ce5-4967-bc3b-2c73df9865af	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	ec6dce85-5c0b-475c-af0b-cbbc034f698f	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals, Inc.	3b3c92b1-bec3-2768-e063-6394a90a9af8	2025-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	f4f026f9-5f21-435e-8878-01dc9bbe2d66	2025-07-10	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Macleods Pharmaceuticals Limited	e05e3314-5520-4bbd-b7f0-623afd9ba569	2025-03-04	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	American Health Packaging	ba764ce4-36fe-4aa4-96a4-d0479b875b4f	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	8857b70b-861d-44f8-a671-78c06c83c029	2024-11-08	Boxed warning, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	d9fe1367-e725-4527-b515-95851d270b18	2024-11-08	Boxed warning, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	24d40f18-b98c-48fc-8d97-5f3e351afc31	2024-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5f5c3ada-db41-4104-9bed-9a56439a7ea2	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	7c214ebf-e0ed-6538-e053-2991aa0a8079	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	7e7cb50d-c984-5c01-e053-2a91aa0a68a5	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	4c74bc01-1065-79f0-f9c4-044ead38a55d	2024-05-22	Warnings, 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.