Application 208358

Type: ANDA
Sponsor: CADILA

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 42.

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
A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	CAPSULE / ORAL	AB		2019-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A208358-001	AB

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 · 42 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
2026-08-18 06:07:40	2026-07	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208358-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208358-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208358-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208358-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208358-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208358-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208358-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208358-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208358-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208358-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208358-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208358-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208358-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208358-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208358-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208358-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208358-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208358-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208358-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208358-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208358-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208358-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208358-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208358-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208358-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208358-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208358-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208358-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208358-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208358-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208358-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208358-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208358-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208358-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208358-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208358-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208358-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208358-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208358-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208358-001	AB	1	`e64feba35796…`

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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	4bc374e2-8650-41bc-8ce6-92062661bf8a	2026-07-01	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	St. Mary's Medical Park Pharmacy	de5e7c85-5bf5-5b5f-e053-2995a90a1fba	2026-06-01	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358 ndc (product): 60760-783
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	08f3885e-dfde-79e4-e063-6394a90a4c09	2025-12-26	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	7dc3414b-dcb5-4b11-bca7-c0fa3f474aea	2025-10-01	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	1fff8245-2b65-4ab1-aaa2-6bbbc6ac5fe8	2025-10-01	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	8857b70b-861d-44f8-a671-78c06c83c029	2024-11-08	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	d9fe1367-e725-4527-b515-95851d270b18	2024-11-08	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	cba87d5b-9302-7b2c-e053-2a95a90a7f9d	2024-04-17	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358 ndc (product): 68071-2533
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5ca13106-f68b-4894-aca2-03e74fff350c	2024-04-03	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358 ndc (product): 71335-2034
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Zydus Lifesciences Limited	e92f1118-8eaf-4fa8-b167-1447550af1ab	2023-10-31	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358 ndc (product): 70771-1474
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Viona Pharmaceuticals Inc	9925ab75-e3b7-43b7-888e-a2c8763240ba	2023-10-31	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358 ndc (product): 72578-090
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Zydus Pharmaceuticals (USA) Inc.	ee11db7b-91bd-4231-8783-889d98e4fa32	2019-02-23	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358 ndc (product): 68382-855

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
60760-783	Triamterene and Hydrochlorothiazide	Triamterene and Hydrochlorothiazide	St Mary's Medical Park Pharmacy	ANDA	Current
68071-2533	Triamterene and Hydrochlorothiazide	Triamterene and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68382-855	Triamterene and Hydrochlorothiazide	Triamterene and Hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1474	Triamterene and Hydrochlorothiazide	Triamterene and Hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1474	Triamterene and Hydrochlorothiazide	Triamterene and Hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
71335-2034	Triamterene and Hydrochlorothiazide	Triamterene and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
72578-090	Triamterene and Hydrochlorothiazide	Triamterene and Hydrochlorothiazide	Viona Pharmaceuticals Inc	ANDA	Current
72578-090	Triamterene and Hydrochlorothiazide	Triamterene and Hydrochlorothiazide	Viona Pharmaceuticals Inc	ANDA	Current
72578-090	Triamterene and Hydrochlorothiazide	Triamterene and Hydrochlorothiazide	Viona Pharmaceuticals Inc	ANDA	Current