Application 091351

Type: ANDA
Sponsor: LUPIN LTD

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 43.

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
A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET / ORAL	2014-08-07
A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET / ORAL	2014-08-07
A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET / ORAL	2014-08-07

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 4 · 129 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	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL		2014-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2014-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL		2014-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL		2014-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2014-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL		2014-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-08-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091351-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-08-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091351-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091351-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-08-07	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A091351-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091351-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091351-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091351-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091351-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091351-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091351-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091351-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091351-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091351-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091351-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091351-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091351-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091351-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091351-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091351-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091351-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091351-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091351-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091351-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091351-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091351-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091351-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091351-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091351-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091351-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091351-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091351-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091351-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091351-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091351-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091351-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A091351-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A091351-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091351-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091351-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091351-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091351-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091351-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091351-003	AB	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Lupin Pharmaceuticals, Inc.	b88054b3-fafa-4b4e-acf5-5294e5555720	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091351 application number: ANDA091351 ndc (product): 68180-193 ndc (product): 68180-194 ndc (product): 68180-195

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
68180-193	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-193	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-193	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-194	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-194	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-194	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-195	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-195	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-195	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current