Application 203010

Type: ANDA
Sponsor: ALEMBIC PHARMS 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	TE codes	Approval date
A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25
A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25
A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET / ORAL	AB	2014-02-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203010-001	AB
A203010-002	AB
A203010-003	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 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	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A203010-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203010-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203010-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203010-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203010-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203010-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203010-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203010-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203010-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203010-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203010-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203010-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203010-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203010-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203010-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203010-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203010-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203010-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203010-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203010-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203010-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203010-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203010-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203010-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203010-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203010-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203010-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203010-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203010-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203010-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203010-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203010-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203010-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203010-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203010-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203010-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203010-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203010-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203010-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203010-001	AB	1	`301d65b070ca…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Inc.	e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7	2023-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203010 application number: ANDA203010 ndc (product): 62332-209 ndc (product): 62332-211 ndc (product): 62332-210
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Limited	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	2023-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203010 application number: ANDA203010 ndc (product): 46708-209 ndc (product): 46708-211 ndc (product): 46708-210

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 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-209	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-209	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-210	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-210	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-211	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-211	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Limited	ANDA	Current
62332-209	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-209	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-209	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-209	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-210	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-210	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-210	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-210	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-211	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-211	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-211	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-211	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
63629-7854	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-7854	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-7854	Telmisartan and Hydrochlorothiazide	Telmisartan and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10145	ORIG	2014-02-27