Application 090149

Type: ANDA
Sponsor: DR REDDYS LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;40MG	No	No
002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB		2011-07-05
A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB		2011-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090149-001	AB
A090149-002	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 3 · 86 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	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090149-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090149-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A090149-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090149-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090149-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090149-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090149-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090149-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090149-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090149-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090149-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090149-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090149-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090149-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090149-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090149-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090149-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090149-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090149-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090149-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090149-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090149-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090149-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090149-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090149-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090149-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090149-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090149-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090149-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090149-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090149-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090149-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090149-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090149-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090149-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090149-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090149-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090149-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090149-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090149-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090149-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090149-002	AB	1	`f41ea6bd6efb…`

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 Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	REMEDYREPACK INC.	2542895b-c8f8-4f21-9e12-f5a7fe17f905	2026-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090149 application number: ANDA090149
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Dr.Reddy's Laboratories Limited	f12f18bb-7ddb-e7dc-4edd-32f4ac212bca	2022-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090149 application number: ANDA090149 ndc (product): 55111-587 ndc (product): 55111-586

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42254-073	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Rebel Distributors Corp	ANDA	Current
42254-074	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Rebel Distributors Corp	ANDA	Current
50090-1463	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	A-S Medication Solutions	ANDA	Current
55111-586	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-586	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-586	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-587	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-587	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-587	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current