Application 207073

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 5MG BASE;20MG	No	No
002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 5MG BASE;40MG	No	No
003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 10MG BASE;20MG	No	No
004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 10MG BASE;40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207073-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-07-17
A207073-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-07-17
A207073-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-07-17
A207073-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A207073-001	AB
A207073-002	AB
A207073-003	AB
A207073-004	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 5 · 172 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
2026-09-14 22:38:34	2026-08	A207073-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207073-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207073-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207073-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207073-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207073-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207073-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207073-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207073-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207073-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207073-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207073-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207073-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207073-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207073-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207073-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207073-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207073-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207073-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207073-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207073-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207073-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207073-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207073-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207073-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207073-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207073-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207073-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207073-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207073-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207073-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207073-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207073-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207073-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207073-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207073-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207073-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207073-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207073-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207073-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-07-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207073-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207073-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207073-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207073-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207073-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207073-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207073-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207073-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207073-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207073-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207073-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207073-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207073-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207073-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207073-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207073-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207073-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207073-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207073-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207073-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207073-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207073-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207073-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207073-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207073-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207073-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207073-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207073-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207073-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207073-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207073-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207073-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207073-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207073-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207073-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207073-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207073-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207073-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207073-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207073-004	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine besylate and Olmesartran medoxomil	AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL	Alembic Pharmaceuticals Inc.	1eb78d80-701d-4766-98c3-feee6790de1a	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207073 application number: ANDA207073 ndc (product): 62332-212 ndc (product): 62332-215 ndc (product): 62332-213 ndc (product): 62332-214
Amlodipine besylate and Olmesartran medoxomil	AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL	Alembic Pharmaceuticals Limited	cb2df7f7-fee8-42ba-8936-0788c4fcc0cb	2023-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207073 application number: ANDA207073 ndc (product): 46708-214 ndc (product): 46708-212 ndc (product): 46708-213 ndc (product): 46708-215

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-212	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Limited	ANDA	Current
46708-212	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Limited	ANDA	Current
46708-213	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Limited	ANDA	Current
46708-213	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Limited	ANDA	Current
46708-214	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Limited	ANDA	Current
46708-214	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Limited	ANDA	Current
46708-215	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Limited	ANDA	Current
46708-215	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Limited	ANDA	Current
62332-212	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-212	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-212	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-212	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-213	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-213	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-213	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-213	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-214	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-214	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-214	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-214	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-215	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-215	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-215	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-215	Amlodipine besylate and Olmesartran medoxomil	Amlodipine besylate and Olmesartran medoxomil	Alembic Pharmaceuticals Inc.	ANDA	Current