Application 207016

Type: ANDA
Sponsor: MICRO LABS

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 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
A207016-001	TELMISARTAN	TELMISARTAN	20MG	TABLET / ORAL	2017-10-03
A207016-002	TELMISARTAN	TELMISARTAN	40MG	TABLET / ORAL	2017-10-03
A207016-003	TELMISARTAN	TELMISARTAN	80MG	TABLET / ORAL	2017-10-03

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	A207016-001	TELMISARTAN	20MG	TABLET / ORAL		2017-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207016-002	TELMISARTAN	40MG	TABLET / ORAL		2017-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207016-003	TELMISARTAN	80MG	TABLET / ORAL		2017-10-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A207016-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207016-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207016-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207016-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207016-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207016-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207016-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207016-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207016-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207016-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207016-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207016-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207016-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207016-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207016-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207016-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207016-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207016-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207016-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207016-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207016-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207016-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207016-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207016-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207016-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207016-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207016-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207016-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207016-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207016-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207016-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207016-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207016-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207016-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207016-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207016-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207016-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207016-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207016-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207016-001	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 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 brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	NuCare Pharmaceuticals, Inc.	3f021f06-99df-48d1-e063-6394a90a8d0f	2025-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
telmisartan	TELMISARTAN	PD-Rx Pharmaceuticals, Inc.	56a72ddf-c2a2-45ce-91b1-1fcfbff52c10	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: telmisartan generic name: TELMISARTAN
telmisartan	TELMISARTAN	Bryant Ranch Prepack	32489e86-0432-4d74-92f6-15e7450f52fa	2025-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: telmisartan generic name: TELMISARTAN
telmisartan	TELMISARTAN	Bryant Ranch Prepack	44e810d4-cf04-41d3-bdf8-0681210a669f	2025-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: telmisartan generic name: TELMISARTAN
telmisartan	TELMISARTAN	Ascend Laboratories, LLC	29bddc43-2809-4e1f-ae35-2865e15e9bb6	2025-03-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Jubilant Cadista Pharmacuticals Inc.	e1a907a7-fad9-a860-8639-4c6136c85734	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	e2deff49-b75e-4aaa-8114-d5ea1e3a94a5	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	b4ae8694-2af4-4acb-8634-b40c1cb6fb41	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	f13e0919-5ee2-4855-b7c8-c8ab423769dd	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Lifestar Pharma LLC	3ff464e6-7a36-4544-a06f-7848414f77fc	2024-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
telmisartan	TELMISARTAN	Zydus Lifesciences Limited	2e3cc412-fa44-4304-aabc-d6e412f81fbf	2024-08-12		Name fallback brand name: telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	NuCare Pharmaceuticals,Inc.	a020e2a7-d1e7-8ae0-e053-2995a90abad3	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Aurobindo Pharma Limited	fef6532d-438a-435e-a61f-216dd8551339	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
telmisartan	TELMISARTAN	Zydus Pharmaceuticals USA Inc.	e61c209a-4fc3-4f5c-b526-6412f0b8897c	2023-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Amneal Pharmaceuticals LLC	20a60231-64f0-4751-aa81-6c0e64334179	2023-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Modavar Pharmaceuticals LLC	a075633a-2a2a-4e88-8ede-b49a3920a16c	2023-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	A-S Medication Solutions	509cd338-24db-41d1-a115-9dc999170717	2023-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Cadila Pharmaceuticals Limited	353fcb30-2fa7-4ff1-8a18-26f3ec279d00	2023-08-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan 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 brand name: Telmisartan 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 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-226	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-226	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-226	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-226	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-226	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-227	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-227	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-227	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-227	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-227	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-228	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-228	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-228	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-228	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
42571-228	TELMISARTAN	Telmisartan	Micro Labs Limited	ANDA	Current
71335-1841	TELMISARTAN	Telmisartan	Bryant Ranch Prepack	ANDA	Current
71335-1841	TELMISARTAN	Telmisartan	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49970	ORIG	2017-10-06