Application 020850

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICARDIS	TELMISARTAN	TABLET;ORAL	40MG	Yes	No
002	MICARDIS	TELMISARTAN	TABLET;ORAL	80MG	Yes	Yes
003	MICARDIS	TELMISARTAN	TABLET;ORAL	20MG	Yes	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	RLD / RS	Approval date
N020850-001	MICARDIS	TELMISARTAN	40MG	TABLET / ORAL	RLD	1998-11-10
N020850-002	MICARDIS	TELMISARTAN	80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-10
N020850-003	MICARDIS	TELMISARTAN	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-04-04

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020850-001	MICARDIS	40MG	TABLET / ORAL		RLD	1998-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020850-002	MICARDIS	80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020850-003	MICARDIS	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020850-001	MICARDIS	40MG	TABLET / ORAL		RLD	1998-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020850-002	MICARDIS	80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020850-003	MICARDIS	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020850-001	MICARDIS	40MG	TABLET / ORAL	AB	RLD	1998-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020850-002	MICARDIS	80MG	TABLET / ORAL		RLD	1998-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020850-003	MICARDIS	20MG	TABLET / ORAL		RLD	2000-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020850-001	MICARDIS	40MG	TABLET / ORAL	AB	RLD	1998-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020850-002	MICARDIS	80MG	TABLET / ORAL		RLD	1998-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020850-003	MICARDIS	20MG	TABLET / ORAL		RLD	2000-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020850-001	MICARDIS	40MG	TABLET / ORAL	AB	RLD	1998-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020850-002	MICARDIS	80MG	TABLET / ORAL		RLD	1998-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020850-003	MICARDIS	20MG	TABLET / ORAL	AB	RLD	2000-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020850-001	MICARDIS	40MG	TABLET / ORAL	AB	RLD	1998-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020850-002	MICARDIS	80MG	TABLET / ORAL	AB	RLD	1998-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020850-003	MICARDIS	20MG	TABLET / ORAL	AB	RLD	2000-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020850-001	MICARDIS	40MG	TABLET / ORAL	AB	RLD	1998-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020850-002	MICARDIS	80MG	TABLET / ORAL	AB	RLD, RS	1998-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020850-003	MICARDIS	20MG	TABLET / ORAL	AB	RLD	2000-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020850-001	MICARDIS	40MG	TABLET / ORAL	AB	RLD	1998-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020850-002	MICARDIS	80MG	TABLET / ORAL	AB	RLD, RS	1998-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020850-003	MICARDIS	20MG	TABLET / ORAL	AB	RLD	2000-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020850-001	MICARDIS	40MG	TABLET / ORAL	AB	RLD	1998-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020850-002	MICARDIS	80MG	TABLET / ORAL	AB	RLD, RS	1998-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020850-003	MICARDIS	20MG	TABLET / ORAL	AB	RLD	2000-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020850-001	MICARDIS	40MG	TABLET / ORAL	AB	RLD	1998-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020850-002	MICARDIS	80MG	TABLET / ORAL	AB	RLD, RS	1998-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020850-003	MICARDIS	20MG	TABLET / ORAL	AB	RLD	2000-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020850-001	MICARDIS	40MG	TABLET / ORAL	AB	RLD	1998-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020850-002	MICARDIS	80MG	TABLET / ORAL	AB	RLD, RS	1998-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020850-003	MICARDIS	20MG	TABLET / ORAL	AB	RLD	2000-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020850-001	MICARDIS	40MG	TABLET / ORAL	AB	RLD	1998-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020850-002	MICARDIS	80MG	TABLET / ORAL	AB	RLD, RS	1998-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020850-003	MICARDIS	20MG	TABLET / ORAL	AB	RLD	2000-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020850-001	MICARDIS	40MG	TABLET / ORAL	AB	RLD	1998-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020850-002	MICARDIS	80MG	TABLET / ORAL	AB	RLD, RS	1998-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020850-003	MICARDIS	20MG	TABLET / ORAL	AB	RLD	2000-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020850-001	MICARDIS	40MG	TABLET / ORAL	AB	RLD	1998-11-10	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 116 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	N020850-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020850-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020850-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020850-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020850-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020850-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020850-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020850-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020850-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020850-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020850-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020850-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020850-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020850-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020850-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020850-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020850-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020850-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020850-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020850-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020850-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020850-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020850-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020850-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020850-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020850-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020850-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020850-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020850-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020850-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020850-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020850-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020850-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020850-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020850-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020850-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020850-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020850-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020850-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020850-003	AB	1	`5c6f7cd8ea54…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020850-001	6358986	2020-01-10			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020850-002	6358986	2020-01-10			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020850-002	7998953	2020-06-06	U-1177	2011-09-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020850-003	6358986	2020-01-10			`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020850-001	6358986	2020-01-10			`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020850-002	6358986	2020-01-10			`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020850-002	7998953	2020-06-06	U-1177	2011-09-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020850-003	6358986	2020-01-10			`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020850-001	6358986	2020-01-10			`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020850-002	6358986	2020-01-10			`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020850-002	7998953	2020-06-06	U-1177	2011-09-09	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020850-003	6358986	2020-01-10			`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020850-001	6358986	2020-01-10			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020850-002	6358986	2020-01-10			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020850-002	7998953	2020-06-06	U-1177	2011-09-09	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020850-003	6358986	2020-01-10			`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020850-001	6358986	2020-01-10			`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020850-002	6358986	2020-01-10			`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020850-002	7998953	2020-06-06	U-1177	2011-09-09	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020850-003	6358986	2020-01-10			`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020850-001	6358986	2020-01-10			`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020850-002	6358986	2020-01-10			`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020850-002	7998953	2020-06-06	U-1177	2011-09-09	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020850-003	6358986	2020-01-10			`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020850-002	8003679	2022-10-06	U-1176	2011-09-09	`f41ea6bd6efb…`

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 2 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	bf8e95fa-d181-4b46-8609-497e14a73dc1	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	NuCare Pharmaceuticals, Inc.	3f021f06-99df-48d1-e063-6394a90a8d0f	2025-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
telmisartan	TELMISARTAN	PD-Rx Pharmaceuticals, Inc.	56a72ddf-c2a2-45ce-91b1-1fcfbff52c10	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
telmisartan	TELMISARTAN	Bryant Ranch Prepack	32489e86-0432-4d74-92f6-15e7450f52fa	2025-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
telmisartan	TELMISARTAN	Bryant Ranch Prepack	44e810d4-cf04-41d3-bdf8-0681210a669f	2025-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
telmisartan	TELMISARTAN	Ascend Laboratories, LLC	29bddc43-2809-4e1f-ae35-2865e15e9bb6	2025-03-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Jubilant Cadista Pharmacuticals Inc.	e1a907a7-fad9-a860-8639-4c6136c85734	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	e2deff49-b75e-4aaa-8114-d5ea1e3a94a5	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	b4ae8694-2af4-4acb-8634-b40c1cb6fb41	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	f13e0919-5ee2-4855-b7c8-c8ab423769dd	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Lifestar Pharma LLC	3ff464e6-7a36-4544-a06f-7848414f77fc	2024-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
telmisartan	TELMISARTAN	Zydus Lifesciences Limited	2e3cc412-fa44-4304-aabc-d6e412f81fbf	2024-08-12		Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	NuCare Pharmaceuticals,Inc.	a020e2a7-d1e7-8ae0-e053-2995a90abad3	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Aurobindo Pharma Limited	fef6532d-438a-435e-a61f-216dd8551339	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
telmisartan	TELMISARTAN	Zydus Pharmaceuticals USA Inc.	e61c209a-4fc3-4f5c-b526-6412f0b8897c	2023-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Amneal Pharmaceuticals LLC	20a60231-64f0-4751-aa81-6c0e64334179	2023-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Modavar Pharmaceuticals LLC	a075633a-2a2a-4e88-8ede-b49a3920a16c	2023-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	A-S Medication Solutions	509cd338-24db-41d1-a115-9dc999170717	2023-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Cadila Pharmaceuticals Limited	353fcb30-2fa7-4ff1-8a18-26f3ec279d00	2023-08-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Amneal Pharmaceuticals of New York LLC	bf2dca37-ce9c-40e4-8ad6-b8186aa7fed1	2023-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TELMISARTAN

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
0054-0542	Telmisartan	telmisartan	West-Ward Pharmaceuticals Corp.	NDA AUTHORIZED GENERIC	Current
0054-0542	Telmisartan	telmisartan	West-Ward Pharmaceuticals Corp.	NDA AUTHORIZED GENERIC	Current
0054-0543	Telmisartan	telmisartan	West-Ward Pharmaceuticals Corp.	NDA AUTHORIZED GENERIC	Current
0054-0543	Telmisartan	telmisartan	West-Ward Pharmaceuticals Corp.	NDA AUTHORIZED GENERIC	Current
0054-0544	Telmisartan	telmisartan	West-Ward Pharmaceuticals Corp.	NDA AUTHORIZED GENERIC	Current
0054-0544	Telmisartan	telmisartan	West-Ward Pharmaceuticals Corp.	NDA AUTHORIZED GENERIC	Current
0597-0039	Micardis	telmisartan	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0039	Micardis	telmisartan	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0039	Micardis	telmisartan	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0039	Micardis	telmisartan	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0040	Micardis	telmisartan	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0040	Micardis	telmisartan	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0040	Micardis	telmisartan	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0040	Micardis	telmisartan	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0041	Micardis	telmisartan	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0041	Micardis	telmisartan	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0041	Micardis	telmisartan	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0041	Micardis	telmisartan	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72984	SUPPL	2022-12-21
72975	SUPPL	2022-12-21
52298	SUPPL	2018-02-02
52262	SUPPL	2018-02-02
35513	SUPPL	2014-12-15
26059	SUPPL	2014-12-15
13618	SUPPL	2012-10-26
3578	SUPPL	2012-10-26
35512	SUPPL	2012-09-24
26057	SUPPL	2012-09-24
35510	SUPPL	2012-01-23
26058	SUPPL	2012-01-23
13617	SUPPL	2012-01-23
3576	SUPPL	2012-01-23
44076	ORIG	2011-12-22
35511	SUPPL	2011-07-12
3577	SUPPL	2011-07-07
26056	SUPPL	2009-11-20
26055	SUPPL	2009-11-19
3575	SUPPL	2009-11-19
13616	SUPPL	2009-10-21
13615	SUPPL	2009-09-17
13614	SUPPL	2009-09-17
3574	SUPPL	2007-03-06
26054	SUPPL	2005-09-08
13613	SUPPL	2005-09-08
35509	SUPPL	2004-05-06
26053	SUPPL	2004-04-07
26052	SUPPL	2003-10-31
41760	ORIG	2001-08-06
35508	ORIG	1998-11-10
3573	ORIG	1998-11-10