Application 206137

Type: ANDA
Sponsor: PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 5MG BASE;12.5MG;20MG	No	No
002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 5MG BASE;12.5MG;40MG	No	No
003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 5MG BASE;25MG;40MG	No	No
004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 10MG BASE;12.5MG;40MG	No	No
005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 10MG BASE;25MG;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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26
A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26
A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26
A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26
A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A206137-001	AB
A206137-002	AB
A206137-003	AB
A206137-004	AB
A206137-005	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 6 · 205 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	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A206137-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206137-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-005	AB	1	`5bbf6a4d5a75…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Par Health USA, LLC	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137 ndc (product): 49884-786 ndc (product): 49884-788 ndc (product): 49884-790 ndc (product): 49884-787 ndc (product): 49884-789
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	57ffeef7-bfa8-4f92-aadc-23cd00022607	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	49ec5ac8-a626-4ab2-9799-8a138920201e	2024-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	204592ba-a68f-452a-9987-1b33b7b6c4d5	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137 ndc (product): 63629-2239
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	be69f132-8b77-4590-a688-cb3709649466	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137 ndc (product): 63629-2241
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	a6ebafdc-4301-4d6c-b578-b3212648b13a	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	b404a550-0df4-404a-8d10-c35e197ca399	2024-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	44dc874b-4377-46eb-ae32-8d84c9c4d4ae	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137 ndc (product): 63629-2238
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	900024f4-23d6-4505-81db-4f643e12858c	2023-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137 ndc (product): 63629-2240

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-786	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-786	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-786	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-786	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-787	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-787	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-787	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-787	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-788	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-788	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-788	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-788	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-789	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-789	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-789	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-789	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-790	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-790	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-790	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
49884-790	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Pharmaceutical, Inc.	ANDA	Current
63629-2238	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-2238	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-2238	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-2239	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-2239	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-2239	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-2240	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-2240	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-2240	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-2241	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-2241	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-2241	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45767	ORIG	2016-11-01
45696	ORIG	2016-10-28