Application 214004

Type: ANDA
Sponsor: SUNSHINE

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 50MG TARTRATE	No	No
002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG TARTRATE	No	No
003	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG TARTRATE	No	No
004	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG TARTRATE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A214004-001	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26
A214004-002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26
A214004-003	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26
A214004-004	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214004-001	AB
A214004-002	AB
A214004-003	AB
A214004-004	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 3 · 92 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	A214004-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214004-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214004-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214004-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214004-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214004-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214004-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214004-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214004-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214004-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214004-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214004-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214004-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214004-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214004-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214004-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214004-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214004-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214004-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214004-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214004-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214004-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214004-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214004-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214004-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214004-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214004-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214004-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214004-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214004-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214004-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214004-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214004-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214004-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214004-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214004-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214004-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214004-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214004-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214004-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 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	A214004-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214004-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214004-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214004-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214004-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214004-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214004-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214004-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214004-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214004-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214004-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214004-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214004-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214004-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214004-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214004-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214004-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214004-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214004-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214004-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214004-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214004-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214004-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214004-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214004-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214004-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214004-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214004-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214004-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214004-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214004-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214004-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214004-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214004-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214004-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214004-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214004-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214004-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214004-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214004-004	AB	1	`d06236e962d9…`

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 3 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOPROL XL	METOPROLOL SUCCINATE	Melinta Therapeutics, LLC	496ddfaa-7c9c-4888-b747-a210249b367a	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	NuCare Pharmaceuticals, Inc.	4b1cfb2f-2345-af53-e063-6294a90a4ff0	2026-02-18	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	BluePoint Laboratories	d92dc643-37b1-4d1e-8fc0-cfb27c3e2702	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	NuCare Pharmaceuticals,Inc.	4a900d2c-12d1-6bfa-e063-6294a90af009	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	860e0ee0-b24f-4eff-b196-b9b03b37d3d5	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Coupler LLC	48ec9246-f887-2ed4-e063-6394a90ac952	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Dr. Reddy's Laboratories Inc	24c87741-ee0a-738e-2c5a-5ce80ca2f48b	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Dr. Reddy's Laboratories Inc	5b7095c8-f8b7-adc7-9052-92325da33a02	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	PD-Rx Pharmaceuticals, Inc.	ff3eaf6a-5697-4ad9-98c4-86925e6da257	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	471f154c-197f-31df-e063-6394a90ae73e	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	NuCare Pharmaceuticals, Inc.	47f96afd-1483-66d5-e063-6294a90a201f	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	REMEDYREPACK INC.	874a38ba-667e-47b6-a918-a972c0e3ed59	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	c213c327-68b7-da5b-e053-2a95a90a4028	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	f80b420c-cc9a-a051-e053-6294a90a8ed9	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	fa160cd3-4349-8e94-e053-6394a90a5887	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	fa16cb4e-d70a-d07f-e053-6294a90a9512	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	f2b4b132-54a5-c875-e053-2a95a90af443	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	f3192894-6298-1b54-e053-2995a90ab2e0	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	f76d782a-59fe-2093-e053-6394a90a8668	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	471bdbd7-7435-6786-e063-6294a90aa8a0	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE