Application 204415

Type: ANDA
Sponsor: AMNEAL PHARMS

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
A204415-001	TELMISARTAN	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08
A204415-002	TELMISARTAN	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08
A204415-003	TELMISARTAN	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204415-001	AB
A204415-002	AB
A204415-003	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	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204415-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2015-09-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204415-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2015-09-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204415-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2015-09-08	`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	A204415-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204415-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204415-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204415-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204415-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204415-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204415-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204415-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204415-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204415-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204415-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204415-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204415-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204415-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204415-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204415-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204415-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204415-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204415-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204415-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204415-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204415-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204415-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204415-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204415-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204415-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204415-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204415-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204415-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204415-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204415-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204415-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204415-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204415-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204415-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204415-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204415-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204415-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204415-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204415-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan	TELMISARTAN	AvKARE	71902893-55da-4286-8b25-b528641489ef	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204415 application number: ANDA204415 ndc (product): 42291-790 ndc (product): 42291-792 ndc (product): 42291-791
Telmisartan	TELMISARTAN	Amneal Pharmaceuticals LLC	20a60231-64f0-4751-aa81-6c0e64334179	2023-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204415 application number: ANDA204415 ndc (product): 65162-292 ndc (product): 65162-291 ndc (product): 65162-293
Telmisartan	TELMISARTAN	Amneal Pharmaceuticals of New York LLC	bf2dca37-ce9c-40e4-8ad6-b8186aa7fed1	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204415 application number: ANDA204415 ndc (product): 53746-291 ndc (product): 53746-292 ndc (product): 53746-293

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-790	Telmisartan	Telmisartan	AvKARE, Inc.	ANDA	Current
42291-790	Telmisartan	Telmisartan	AvKARE, Inc.	ANDA	Current
42291-790	Telmisartan	Telmisartan	AvKARE	ANDA	Current
42291-790	Telmisartan	Telmisartan	AvKARE	ANDA	Current
42291-791	Telmisartan	Telmisartan	AvKARE, Inc.	ANDA	Current
42291-791	Telmisartan	Telmisartan	AvKARE, Inc.	ANDA	Current
42291-791	Telmisartan	Telmisartan	AvKARE	ANDA	Current
42291-791	Telmisartan	Telmisartan	AvKARE	ANDA	Current
42291-792	Telmisartan	Telmisartan	AvKARE, Inc.	ANDA	Current
42291-792	Telmisartan	Telmisartan	AvKARE, Inc.	ANDA	Current
42291-792	Telmisartan	Telmisartan	AvKARE	ANDA	Current
42291-792	Telmisartan	Telmisartan	AvKARE	ANDA	Current
53746-291	Telmisartan	Telmisartan	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-291	Telmisartan	Telmisartan	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-291	Telmisartan	Telmisartan	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-292	Telmisartan	Telmisartan	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-292	Telmisartan	Telmisartan	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-292	Telmisartan	Telmisartan	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-293	Telmisartan	Telmisartan	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-293	Telmisartan	Telmisartan	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-293	Telmisartan	Telmisartan	Amneal Pharmaceuticals of New York LLC	ANDA	Current
65162-291	Telmisartan	Telmisartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-291	Telmisartan	Telmisartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-291	Telmisartan	Telmisartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-291	Telmisartan	Telmisartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-292	Telmisartan	Telmisartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-292	Telmisartan	Telmisartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-292	Telmisartan	Telmisartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-292	Telmisartan	Telmisartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-293	Telmisartan	Telmisartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-293	Telmisartan	Telmisartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-293	Telmisartan	Telmisartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-293	Telmisartan	Telmisartan	Amneal Pharmaceuticals LLC	ANDA	Current