Application 202397

Type: ANDA
Sponsor: MYLAN

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
A202397-001	TELMISARTAN	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07
A202397-002	TELMISARTAN	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07
A202397-003	TELMISARTAN	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202397-001	AB
A202397-002	AB
A202397-003	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	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202397-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202397-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202397-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`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	A202397-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202397-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202397-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202397-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202397-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202397-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202397-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202397-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202397-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202397-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202397-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202397-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202397-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202397-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202397-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202397-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202397-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202397-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202397-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202397-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202397-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202397-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202397-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202397-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202397-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202397-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202397-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202397-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202397-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202397-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202397-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202397-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202397-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202397-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202397-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202397-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202397-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202397-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202397-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202397-001	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	A-S Medication Solutions	eaed12cd-5bfe-4c98-9afc-025ed86a294f	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202397 application number: ANDA202397 ndc (product): 50090-5490
Telmisartan	TELMISARTAN	A-S Medication Solutions	509cd338-24db-41d1-a115-9dc999170717	2023-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202397 application number: ANDA202397 ndc (product): 50090-5492
Telmisartan	TELMISARTAN	Mylan Pharmaceuticals Inc.	c3658bc8-1524-43db-930e-66f9ac01b808	2023-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202397 application number: ANDA202397 ndc (product): 0378-2922 ndc (product): 0378-2921 ndc (product): 0378-2920

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2920	Telmisartan	telmisartan	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2920	Telmisartan	telmisartan	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2921	Telmisartan	telmisartan	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2921	Telmisartan	telmisartan	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2922	Telmisartan	telmisartan	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2922	Telmisartan	telmisartan	Mylan Pharmaceuticals Inc.	ANDA	Current
50090-5489	Telmisartan	telmisartan	A-S Medication Solutions	ANDA	Current
50090-5490	Telmisartan	telmisartan	A-S Medication Solutions	ANDA	Current
50090-5492	Telmisartan	telmisartan	A-S Medication Solutions	ANDA	Current