Application 077298

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

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 100MG TARTRATE	No	No
002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077298-001	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL			2010-04-15
A077298-002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL			2010-04-15

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 · 82 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	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2010-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2010-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077298-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077298-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077298-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077298-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077298-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077298-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077298-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077298-002	AB	1	`ea99ee380514…`

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 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	REMEDYREPACK INC.	76c69d7c-e90c-4f96-a45b-e9dad9444263	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	BluePoint Laboratories	6588d77c-090f-4722-9c91-437887d4624a	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol succinate	METOPROLOL SUCCINATE	Aphena Pharma Solutions - Tennessee, LLC	52bdc5cc-973f-4af6-e063-6294a90aba22	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Coupler LLC	55f1a53b-8ec1-8373-e063-6394a90a896c	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Coupler LLC	55f20cc3-d958-bd74-e063-6394a90a7850	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL SUCCINATE generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Coupler LLC	55f47fad-ddc9-d9e6-e063-6394a90a48cf	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	PD-Rx Pharmaceuticals, Inc.	98a39051-be63-4120-b247-50796656bd7c	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	a1997b48-8d66-437a-a253-ca996331b0c3	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	adc8234b-192a-4ca4-a949-3eabc11af525	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	9c33fc53-35d1-4b01-a805-ae737405db3f	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Preferred Pharmaceuticals Inc	0ded3105-b962-4748-bf5b-fca7a4557562	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	6da0e3dc-1b11-4975-b35c-5a6ca13cf990	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Preferred Pharmaceuticals Inc.	7dfe56fe-68b6-4897-9238-0f530c92e27e	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL SUCCINATE generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	d58b56cc-1a3d-4147-afc2-12e8236c3766	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	471bca3e-3401-6814-e063-6394a90a9cb1	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	REMEDYREPACK INC.	c2eb2a77-761a-49c0-9eca-8eb57d8532d2	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Cardinal Health 107, LLC	450fb603-73d7-422b-a4e2-5a05c13ebe3b	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	St. Mary's Medical Park Pharmacy	0a99ed82-2ee8-6f9c-e063-6394a90ac7ba	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	ST. MARY'S MEDICAL PARK PHARMACY	4136f1e3-b8f4-cb6c-e063-6294a90a03c2	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	St Mary's Medical Park Pharmacy	cdb69427-0489-3751-e053-2995a90a3667	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-972	Metoprolol Succinate	Metoprolol Succinate	Rebel Distributors Corp	ANDA	Current
43353-795	Metoprolol Succinate	Metoprolol Succinate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-3383	Metoprolol Succinate	Metoprolol Succinate	A-S Medication Solutions	ANDA	Current
50090-3383	Metoprolol Succinate	Metoprolol Succinate	A-S Medication Solutions	ANDA	Current
60429-141	Metoprolol Succinate	Metoprolol Succinate	Golden State Medical Supply, Inc.	ANDA	Current
60429-141	Metoprolol Succinate	Metoprolol Succinate	Golden State Medical Supply, Inc.	ANDA	Current
60429-141	Metoprolol Succinate	Metoprolol Succinate	Golden State Medical Supply, Inc.	ANDA	Current
60429-142	Metoprolol Succinate	Metoprolol Succinate	Golden State Medical Supply, Inc.	ANDA	Current
60429-142	Metoprolol Succinate	Metoprolol Succinate	Golden State Medical Supply, Inc.	ANDA	Current
60429-142	Metoprolol Succinate	Metoprolol Succinate	Golden State Medical Supply, Inc.	ANDA	Current
62037-832	Metoprolol Succinate	Metoprolol Succinate	Actavis Pharma, Inc.	ANDA	Current
62037-832	Metoprolol Succinate	Metoprolol Succinate	Actavis Pharma, Inc.	ANDA	Current
62037-832	Metoprolol Succinate	Metoprolol Succinate	Actavis Pharma, Inc.	ANDA	Current
62037-832	Metoprolol Succinate	Metoprolol Succinate	Actavis Pharma, Inc.	ANDA	Current
62037-832	Metoprolol Succinate	Metoprolol Succinate	Actavis Pharma, Inc.	ANDA	Current
62037-833	Metoprolol Succinate	Metoprolol Succinate	Actavis Pharma, Inc.	ANDA	Current
62037-833	Metoprolol Succinate	Metoprolol Succinate	Actavis Pharma, Inc.	ANDA	Current
62037-833	Metoprolol Succinate	Metoprolol Succinate	Actavis Pharma, Inc.	ANDA	Current
62037-833	Metoprolol Succinate	Metoprolol Succinate	Actavis Pharma, Inc.	ANDA	Current
63187-547	Metoprolol Succinate	Metoprolol Succinate	Proficient Rx LP	ANDA	Current
63187-547	Metoprolol Succinate	Metoprolol Succinate	Proficient Rx LP	ANDA	Current
63629-4387	Metoprolol Succinate ER	Metoprolol Succinate	Bryant Ranch Prepack	ANDA	Current
63629-4387	Metoprolol Succinate ER	Metoprolol Succinate	Bryant Ranch Prepack	ANDA	Current
63739-454	Metoprolol Succinate	Metoprolol Succinate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-454	Metoprolol Succinate	Metoprolol Succinate	McKesson Corporation	ANDA	Current
68071-1923	Metoprolol Succinate	Metoprolol Succinate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-6785	Metoprolol Succinate	Metoprolol Succinate	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0611	Metoprolol Succinate	Metoprolol Succinate	REMEDYREPACK INC.	ANDA	Current
70518-0611	Metoprolol Succinate	Metoprolol Succinate	REMEDYREPACK INC.	ANDA	Current
70518-0611	Metoprolol Succinate	Metoprolol Succinate	REMEDYREPACK INC.	ANDA	Current