Application 202130

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TELMISARTAN	TELMISARTAN	TABLET;ORAL	20MG	No	No
002	TELMISARTAN	TELMISARTAN	TABLET;ORAL	40MG	No	No
003	TELMISARTAN	TELMISARTAN	TABLET;ORAL	80MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202130-001	TELMISARTAN	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07
A202130-002	TELMISARTAN	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07
A202130-003	TELMISARTAN	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202130-001	AB
A202130-002	AB
A202130-003	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 · 126 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	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202130-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202130-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202130-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A202130-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202130-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202130-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202130-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202130-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202130-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202130-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202130-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202130-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202130-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202130-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202130-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202130-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202130-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202130-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202130-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202130-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202130-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202130-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202130-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202130-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202130-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202130-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202130-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202130-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202130-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202130-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202130-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202130-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202130-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202130-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202130-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202130-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202130-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202130-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202130-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202130-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202130-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202130-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202130-001	AB	1	`1e350fbaab3a…`

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	TELMISARTAN	Alembic Pharmaceuticals Limited	4be6575f-ea8d-4cd8-a49d-3d1c93f2621a	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202130 application number: ANDA202130 ndc (product): 46708-609 ndc (product): 46708-610 ndc (product): 46708-608
Telmisartan	TELMISARTAN	Alembic Pharmaceuticals Inc.	c62d424c-7630-413c-be2c-3932831c3f1d	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202130 application number: ANDA202130 ndc (product): 62332-089 ndc (product): 62332-088 ndc (product): 62332-087

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-836	Telmisartan	Telmisartan	medsource pharmaceuticals	ANDA	Current
46708-608	Telmisartan	Telmisartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-609	Telmisartan	Telmisartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-610	Telmisartan	Telmisartan	Alembic Pharmaceuticals Limited	ANDA	Current
62332-087	Telmisartan	Telmisartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-087	Telmisartan	Telmisartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-087	Telmisartan	Telmisartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-088	Telmisartan	Telmisartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-088	Telmisartan	Telmisartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-088	Telmisartan	Telmisartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-089	Telmisartan	Telmisartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-089	Telmisartan	Telmisartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-089	Telmisartan	Telmisartan	Alembic Pharmaceuticals Inc.	ANDA	Current