Application 215637

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG TARTRATE	No	No
002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG TARTRATE	No	No
003	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG TARTRATE	No	No
004	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG TARTRATE	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	Approval date
A215637-001	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18
A215637-002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18
A215637-003	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18
A215637-004	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18

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 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215637-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215637-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215637-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215637-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215637-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215637-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215637-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215637-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215637-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215637-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215637-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215637-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215637-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215637-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215637-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215637-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215637-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215637-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215637-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215637-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215637-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215637-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215637-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215637-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215637-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215637-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215637-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215637-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215637-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215637-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215637-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215637-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215637-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215637-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215637-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215637-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215637-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215637-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215637-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215637-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	2022-10-18	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A215637-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A215637-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A215637-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A215637-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215637-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215637-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215637-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215637-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215637-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215637-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215637-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215637-004	AB	1	`3a93d1ddd44b…`

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 8 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	42bb324d-8b1e-45db-b15e-3845eec83c38	2023-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	26d22b60-4414-40e3-9157-5e67340a0106	2023-10-27	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE	Proficient Rx LP	502653e6-1971-4abf-9b21-ba0a9957672b	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	A-S Medication Solutions	a022ac8a-15dc-4606-95c2-d7de176a3561	2023-09-17	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	A-S Medication Solutions	c8c02764-ef49-4ee4-a3b1-9660cf0e582d	2023-09-17	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	A-S Medication Solutions	b89de581-2a6f-4dc2-ae82-ae6a6a209966	2023-09-17	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	e780699f-d795-44ce-9828-a0caa6283fb3	2023-09-11	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	A-S Medication Solutions	91e401fe-ec92-494e-9966-35c280f23efa	2023-09-05	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL SUCCINATE generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	A-S Medication Solutions	820a962a-5b15-4beb-bd78-e1ac10cb2e0e	2023-09-05	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL SUCCINATE generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	A-S Medication Solutions	907a35b0-3e0b-40bb-93fd-62b137454b62	2023-08-24	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	BluePoint Laboratories	6a4f2446-a9e4-479a-87bd-2d5539dcded9	2023-08-08	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL SUCCINATE generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Bryant Ranch Prepack	5bf27a6c-ea3f-425e-9cfc-a5a308e2af1c	2023-07-11	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL SUCCINATE generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	A-S Medication Solutions	8bdc7ee4-bf10-4ee7-aa82-3a2d20e4bc2f	2023-06-15	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	5ee51a50-0187-4156-84fa-95e68f5c353b	2023-05-19	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Proficient Rx LP	57e33bcf-b380-44bb-b96e-3a637af6233a	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Proficient Rx LP	64c65611-d5c9-4802-9edd-32c7c67ce6f4	2023-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	e91e8ee2-4a54-4932-9d8b-5831121377a4	2023-04-30	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
KAPSPARGO	METOPROLOL SUCCINATE	Sun Pharmaceutical Industries, Inc.	9cfa55b4-15c6-40f7-b6e5-41096ee51bfc	2023-04-12	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Cipla USA Inc.	3a4966a2-2728-4c99-999f-576b3e2df90c	2023-04-07	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL SUCCINATE generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Dr. Reddy's Laboratories Limited	90594d68-87f2-5f75-2d8a-1629f88ba8a9	2023-03-20	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE

Reported adverse events (FAERS/openFDA)#

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