Application 206763

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A206763-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24
A206763-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24
A206763-003	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
A206763-001	AB
A206763-002	AB
A206763-003	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	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206763-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206763-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206763-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206763-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206763-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206763-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206763-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206763-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206763-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206763-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206763-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206763-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206763-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206763-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206763-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206763-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206763-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206763-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206763-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206763-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206763-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206763-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206763-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206763-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206763-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206763-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206763-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206763-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206763-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206763-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206763-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206763-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206763-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206763-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206763-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206763-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206763-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206763-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206763-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206763-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206763-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206763-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206763-001	AB	1	`8072bd15b7f6…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	REMEDYREPACK INC.	92969ed0-8dcd-4c6d-b0c4-e8469c2f65a9	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206763 application number: ANDA206763 ndc (product): 70518-1343
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	eeb16efc-4413-4464-9eb8-effa1e5684aa	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206763 application number: ANDA206763
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	26065167-37c9-4e95-aa2c-3005b6805a52	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206763 application number: ANDA206763 ndc (product): 50090-3656
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	REMEDYREPACK INC.	33429d86-878e-4e1e-a940-70a8a56a15ea	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206763 application number: ANDA206763 ndc (product): 70518-1345
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	cae6cb47-0a2c-4c69-894b-89d389cab49f	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206763 application number: ANDA206763
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	04f0107b-4194-4412-9ebb-3219da5a9ac9	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206763 application number: ANDA206763 ndc (product): 50090-3655
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	eff499eb-a0e4-4240-870c-83bb53434cc2	2025-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206763 application number: ANDA206763
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	e43e5643-b258-469d-812a-887f913cfe71	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206763 application number: ANDA206763
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Ascend Laboratories, LLC	142b735a-e1cd-46e1-a523-3ef061001bf9	2025-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206763 application number: ANDA206763 ndc (product): 67877-445 ndc (product): 67877-447 ndc (product): 67877-446
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Proficient Rx LP	eff8b514-bb7f-427e-a267-7dee25fff611	2024-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206763 application number: ANDA206763 ndc (product): 71205-458 ndc (product): 71205-459
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	afcfc1eb-29b1-46e8-a013-5cbb1737a232	2024-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206763 application number: ANDA206763

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3655	Olmesartan Medoxomil	Olmesartan Medoxomil	A-S Medication Solutions	ANDA	Current
50090-3655	Olmesartan Medoxomil	Olmesartan Medoxomil	A-S Medication Solutions	ANDA	Current
50090-3655	Olmesartan Medoxomil	Olmesartan Medoxomil	A-S Medication Solutions	ANDA	Current
50090-3655	Olmesartan Medoxomil	Olmesartan Medoxomil	A-S Medication Solutions	ANDA	Current
50090-3656	Olmesartan Medoxomil	Olmesartan Medoxomil	A-S Medication Solutions	ANDA	Current
50090-3656	Olmesartan Medoxomil	Olmesartan Medoxomil	A-S Medication Solutions	ANDA	Current
50090-3656	Olmesartan Medoxomil	Olmesartan Medoxomil	A-S Medication Solutions	ANDA	Current
50090-3656	Olmesartan Medoxomil	Olmesartan Medoxomil	A-S Medication Solutions	ANDA	Current
67877-445	Olmesartan Medoxomil	Olmesartan Medoxomil	Ascend Laboratories, LLC	ANDA	Current
67877-445	Olmesartan Medoxomil	Olmesartan Medoxomil	Ascend Laboratories, LLC	ANDA	Current
67877-445	Olmesartan Medoxomil	Olmesartan Medoxomil	Ascend Laboratories, LLC	ANDA	Current
67877-446	Olmesartan Medoxomil	Olmesartan Medoxomil	Ascend Laboratories, LLC	ANDA	Current
67877-446	Olmesartan Medoxomil	Olmesartan Medoxomil	Ascend Laboratories, LLC	ANDA	Current
67877-446	Olmesartan Medoxomil	Olmesartan Medoxomil	Ascend Laboratories, LLC	ANDA	Current
67877-447	Olmesartan Medoxomil	Olmesartan Medoxomil	Ascend Laboratories, LLC	ANDA	Current
67877-447	Olmesartan Medoxomil	Olmesartan Medoxomil	Ascend Laboratories, LLC	ANDA	Current
67877-447	Olmesartan Medoxomil	Olmesartan Medoxomil	Ascend Laboratories, LLC	ANDA	Current
70518-1343	Olmesartan Medoxomil	Olmesartan Medoxomil	REMEDYREPACK INC.	ANDA	Current
70518-1343	Olmesartan Medoxomil	Olmesartan Medoxomil	REMEDYREPACK INC.	ANDA	Current
70518-1345	Olmesartan Medoxomil	Olmesartan Medoxomil	REMEDYREPACK INC.	ANDA	Current
70518-1345	Olmesartan Medoxomil	Olmesartan Medoxomil	REMEDYREPACK INC.	ANDA	Current
71205-458	Olmesartan Medoxomil	Olmesartan Medoxomil	Proficient Rx LP	ANDA	Current
71205-459	Olmesartan Medoxomil	Olmesartan Medoxomil	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48113	ORIG	2017-04-26