Application 208360

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	TABLET;ORAL	25MG;37.5MG	No	No
002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	TABLET;ORAL	50MG;75MG	No	No

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
A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	TABLET / ORAL	AB		2018-06-29
A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	50MG;75MG	TABLET / ORAL	AB		2018-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A208360-001	AB
A208360-002	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 3 · 86 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	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208360-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2018-06-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208360-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2018-06-29	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208360-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208360-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208360-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208360-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208360-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208360-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208360-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208360-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208360-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208360-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208360-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208360-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208360-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208360-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208360-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208360-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208360-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208360-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208360-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208360-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208360-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208360-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208360-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208360-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208360-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208360-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208360-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208360-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208360-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208360-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208360-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208360-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208360-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208360-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208360-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208360-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208360-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208360-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208360-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208360-002	AB	1	`74a2ff9319b5…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
triamterene and hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	839216fd-5eac-4550-8baa-ad77b91c5de7	2023-11-24	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208360 application number: ANDA208360 ndc (product): 50090-5801
triamterene and hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	27b8f965-d73f-411c-aae6-bcae6e281113	2023-10-23	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208360 application number: ANDA208360
triamterene and hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Zydus Lifesciences Limited	1af80800-e7a5-42e5-aa6c-3f61aff4a77b	2023-08-31	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208360 application number: ANDA208360 ndc (product): 70771-1361 ndc (product): 70771-1362
triamterene and hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Zydus Pharmaceuticals (USA) Inc.	fa69eeb8-ec82-4be1-8cb7-f64094ed957c	2023-08-26	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208360 application number: ANDA208360 ndc (product): 68382-857 ndc (product): 68382-856
triamterene and hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	236dead0-16d5-4383-860f-30743730a088	2021-10-28	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208360 application number: ANDA208360 ndc (product): 71610-602

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5801	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
68382-856	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-856	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-856	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-857	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-857	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-857	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1361	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1361	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1361	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1362	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1362	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1362	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
71610-602	triamterene and hydrochlorothiazide	triamterene and hydrochlorothiazide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current