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

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207016-001	AB
A207016-002	AB
A207016-003	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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`1e350fbaab3a…`

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 1 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan	TELMISARTAN	REMEDYREPACK INC.	57da6ef2-2e86-4e4d-90df-73a2a8cf97f6	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	REMEDYREPACK INC.	91215664-6e19-4e04-9ae7-ab5664799426	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Redpharm Drug	5743c58e-deab-ac93-e063-6294a90ac1eb	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
telmisartan	TELMISARTAN	REMEDYREPACK INC.	09d31eee-cd22-4918-a889-3eb4d2969525	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Alembic Pharmaceuticals Limited	4be6575f-ea8d-4cd8-a49d-3d1c93f2621a	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Alembic Pharmaceuticals Inc.	c62d424c-7630-413c-be2c-3932831c3f1d	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	830741dd-3f3c-4f8e-88c6-dc112166f477	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	a5ded796-3555-4476-8b37-0cdc88d7594a	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	c55e4fe1-f04d-4995-a706-9f432fde57e4	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Glenmark Pharmaceuticals Inc., USA	c6eb489d-2946-4c14-839f-d4af761ead31	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Macleods Pharmaceuticals Limited	671d5a85-4146-43b4-9d7d-ca53268eb2a6	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	AvKARE	71902893-55da-4286-8b25-b528641489ef	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Solco Healthcare US, LLC	77442f0b-b522-4b19-ac1f-f0ce8576f0be	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	A-S Medication Solutions	eaed12cd-5bfe-4c98-9afc-025ed86a294f	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
TELMISARTAN	TELMISARTAN	Chartwell RX, LLC.	beaaf383-730f-4411-b5e7-15c32b53a338	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TELMISARTAN generic name: TELMISARTAN
Telmisartan	TELMISARTAN	NorthStar RxLLC	9c22a318-d1f2-4788-9331-66fed71ebf38	2025-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	f6da5155-9c26-46bb-bc0f-ece4ea21405f	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: telmisartan generic name: TELMISARTAN
telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	dd2b0604-f887-40d9-9109-dafcc9987e4e	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: telmisartan generic name: TELMISARTAN
Telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	d45da80a-58c3-4461-adf6-a85531c09eb8	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan generic name: TELMISARTAN
telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	963e9245-ec7a-4bf6-9fc0-80f54e3657f0	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: telmisartan generic name: TELMISARTAN

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