Application 205482

Type: ANDA
Sponsor: JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	TABLET;ORAL	5MG	No	No
002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	TABLET;ORAL	20MG	No	No
003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	TABLET;ORAL	40MG	No	No

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

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
A205482-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24
A205482-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24
A205482-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205482-001	AB
A205482-002	AB
A205482-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205482-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205482-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205482-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205482-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205482-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205482-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205482-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205482-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205482-003	AB	1	`6a471c1ec25d…`
2019-12-13 00:20 UTC	2019-12	A205482-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205482-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205482-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A205482-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205482-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205482-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205482-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205482-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205482-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205482-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205482-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205482-003	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205482-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205482-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205482-003	AB	1	`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
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Jubilant Cadista Pharmacuticals Inc.	d5658d8a-f8e9-454d-89a9-34884e753001	2025-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205482 application number: ANDA205482 ndc (product): 59746-465 ndc (product): 59746-463 ndc (product): 59746-466

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59746-463	olmesartan medoxomil	olmesartan medoxomil	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-463	olmesartan medoxomil	olmesartan medoxomil	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-465	olmesartan medoxomil	olmesartan medoxomil	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-465	olmesartan medoxomil	olmesartan medoxomil	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-466	olmesartan medoxomil	olmesartan medoxomil	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-466	olmesartan medoxomil	olmesartan medoxomil	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current