Application 214489

Type: ANDA
Sponsor: LUPIN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZILSARTAN MEDOXOMIL	AZILSARTAN MEDOXOMIL	TABLET; ORAL	40MG	No	No
002	AZILSARTAN MEDOXOMIL	AZILSARTAN MEDOXOMIL	TABLET; ORAL	80MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214489-001	AZILSARTAN MEDOXOMIL	AZILSARTAN KAMEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	AB		2022-07-20
A214489-002	AZILSARTAN MEDOXOMIL	AZILSARTAN KAMEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	AB		2022-07-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214489-001	AB
A214489-002	AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A214489-001	PC	2026-12-12
A214489-002	PC	2026-12-12

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 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`a67488948f0b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214489-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214489-002	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214489-001	PC	2026-12-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214489-002	PC	2026-12-12	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azilsartan medoxomil	AZILSARTAN MEDOXOMIL	Lupin Pharmaceuticals, Inc.	b1c8de43-3b26-408f-8c7e-6c7d76348199	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214489 application number: ANDA214489

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69860	ORIG	2022-01-12