Application 201192

Type: ANDA
Sponsor: TORRENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	TABLET;ORAL	12.5MG;40MG	No	No
002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	TABLET;ORAL	12.5MG;80MG	No	No
003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	TABLET;ORAL	25MG;80MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET / ORAL	2014-02-25
A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET / ORAL	2014-02-25
A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET / ORAL	2014-02-25

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 3 of 4 · 132 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
2020-11-12 02:37 UTC	2020-11	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL		2014-02-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2014-02-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL		2014-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL		2014-02-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2014-02-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL		2014-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL		2014-02-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2014-02-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL		2014-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL		2014-02-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2014-02-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL		2014-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL		2014-02-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2014-02-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL		2014-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL		2014-02-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2014-02-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL		2014-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL		2014-02-25	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2014-02-25	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL		2014-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL		2014-02-25	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2014-02-25	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL		2014-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL		2014-02-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2014-02-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL		2014-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201192-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL		2014-02-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201192-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2014-02-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201192-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL		2014-02-25	`3a93d1ddd44b…`

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	A201192-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201192-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201192-003	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A201192-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201192-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201192-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201192-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201192-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201192-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201192-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201192-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201192-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201192-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201192-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201192-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201192-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201192-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201192-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201192-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201192-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201192-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201192-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201192-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201192-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201192-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201192-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201192-003	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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	AvKARE	1b303136-dccd-178b-e063-6394a90a35f8	2026-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan and Hydrochlorothiazide
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Lupin Pharmaceuticals, Inc.	b88054b3-fafa-4b4e-acf5-5294e5555720	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan and Hydrochlorothiazide
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Glenmark Pharmaceuticals Inc., USA	1e55800d-f77c-4950-a6d7-2055f4c7ea17	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan and Hydrochlorothiazide
telmisartan and hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Lifestar Pharma LLC	0c1bd0f4-034e-486c-ae46-2855c8c9ebda	2025-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: telmisartan and hydrochlorothiazide
TELMISARTAN AND HYDROCHLOROTHIAZIDE	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Solco Healthcare LLC	47c8eee0-f0b7-4bd8-97e9-0029aa1b37db	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TELMISARTAN AND HYDROCHLOROTHIAZIDE
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	681dfb5c-fc5c-427e-81f6-4b4e934978a2	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan and Hydrochlorothiazide
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Inc.	e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7	2023-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan and Hydrochlorothiazide
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Limited	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	2023-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan 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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-159	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-159	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-159	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-159	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-159	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-159	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-160	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-160	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-160	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-160	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-160	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-160	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-161	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-161	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-161	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-161	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-161	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-161	telmisartan and hydrochlorthiazide	telmisartan and hydrochlorthiazide	Torrent Pharmaceuticals Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9864	ORIG	2014-02-27