Application 205150

Type: ANDA
Sponsor: INVENTIA

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 1.

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	RLD / RS	Approval date
A205150-001	TELMISARTAN	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30
A205150-002	TELMISARTAN	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30
A205150-003	TELMISARTAN	TELMISARTAN	80MG	TABLET / ORAL	AB	RS	2015-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205150-001	AB
A205150-002	AB
A205150-003	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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB	RS	2015-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB	RS	2015-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB	RS	2015-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB	RS	2015-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205150-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205150-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205150-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205150-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205150-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205150-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205150-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205150-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205150-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205150-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205150-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205150-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205150-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205150-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205150-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205150-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205150-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205150-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205150-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205150-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205150-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205150-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205150-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205150-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205150-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205150-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205150-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205150-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205150-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205150-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205150-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205150-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205150-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205150-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205150-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205150-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205150-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205150-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205150-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205150-001	AB	1	`8072bd15b7f6…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
telmisartan	TELMISARTAN	REMEDYREPACK INC.	09d31eee-cd22-4918-a889-3eb4d2969525	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	f6da5155-9c26-46bb-bc0f-ece4ea21405f	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	dd2b0604-f887-40d9-9109-dafcc9987e4e	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	963e9245-ec7a-4bf6-9fc0-80f54e3657f0	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	PD-Rx Pharmaceuticals, Inc.	56a72ddf-c2a2-45ce-91b1-1fcfbff52c10	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	Bryant Ranch Prepack	32489e86-0432-4d74-92f6-15e7450f52fa	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150 ndc (product): 71335-1428
telmisartan	TELMISARTAN	Bryant Ranch Prepack	44e810d4-cf04-41d3-bdf8-0681210a669f	2025-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150 ndc (product): 63629-5682
telmisartan	TELMISARTAN	Ascend Laboratories, LLC	29bddc43-2809-4e1f-ae35-2865e15e9bb6	2025-03-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150 ndc (product): 67877-483 ndc (product): 67877-482 ndc (product): 67877-484
telmisartan	TELMISARTAN	Proficient Rx LP	593a53a4-91bc-4e4a-aeff-08fc2efe3dd4	2020-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150 ndc (product): 63187-951

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
63187-951	telmisartan	telmisartan	Proficient Rx LP	ANDA	Current
63187-951	telmisartan	telmisartan	Proficient Rx LP	ANDA	Current
63187-951	telmisartan	telmisartan	Proficient Rx LP	ANDA	Current
63629-5682	telmisartan	telmisartan	Bryant Ranch Prepack	ANDA	Current
67877-482	telmisartan	telmisartan	Ascend Laboratories, LLC	ANDA	Current
67877-482	telmisartan	telmisartan	Ascend Laboratories, LLC	ANDA	Current
67877-482	telmisartan	telmisartan	Ascend Laboratories, LLC	ANDA	Current
67877-483	telmisartan	telmisartan	Ascend Laboratories, LLC	ANDA	Current
67877-483	telmisartan	telmisartan	Ascend Laboratories, LLC	ANDA	Current
67877-483	telmisartan	telmisartan	Ascend Laboratories, LLC	ANDA	Current
67877-484	telmisartan	telmisartan	Ascend Laboratories, LLC	ANDA	Current
67877-484	telmisartan	telmisartan	Ascend Laboratories, LLC	ANDA	Current
67877-484	telmisartan	telmisartan	Ascend Laboratories, LLC	ANDA	Current
68071-2591	telmisartan	telmisartan	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4937	telmisartan	telmisartan	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4937	telmisartan	telmisartan	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-1428	telmisartan	telmisartan	Bryant Ranch Prepack	ANDA	Current
71335-1428	telmisartan	telmisartan	Bryant Ranch Prepack	ANDA	Current