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 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
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 · 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	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077298-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077298-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL		2010-04-15	`caaa826d4ba7…`
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…`

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 7 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	A-S Medication Solutions	712e8b44-c659-4344-8550-ce43f9422300	2024-12-03	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Actavis Pharma, Inc.	b798601e-a369-4c8b-8235-08900e1b751d	2024-12-01	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	ef628c06-756b-4f17-9960-439eaf715444	2024-11-07	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol succinate	METOPROLOL SUCCINATE	NCS HealthCare of KY, LLC dba Vangard Labs	53613463-d5b6-41e7-aa43-1b75633c61fd	2024-09-24	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	a644027d-6f66-4467-a9ac-2ebcf2839744	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	2f7730bb-74ac-488b-965a-7dcdaac9d6e4	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
metoprolol succinate	METOPROLOL SUCCINATE	NuCare Pharmaceuticals,Inc.	ca8dbdc1-0137-8a89-e053-2995a90a66fd	2024-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	NuCare Pharmaceuticals,Inc.	a849d489-8f8c-18e6-e053-2995a90a3770	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METOPROLOL SUCCINATE generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	6103540c-93b5-46e8-9ef3-5059fa0335ab	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Granules Pharmaceuticals Inc.	ff180ca2-7490-a571-e053-6394a90a97b1	2024-07-05	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	aa1c7d31-78be-465f-9564-03685a58add8	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	f09d07f1-e0d1-444d-8e8a-f340f7377c8d	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Slate Run Pharmaceuticals, LLC	c00f99e2-7a88-6f9b-e053-2995a90a6ace	2024-05-17	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	NuCare Pharmaceuticals,Inc.	d96a039f-c3e5-4749-e053-2995a90abcb2	2024-03-25	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	342846fb-d42f-4d96-a8b5-7bcf1dcaef2f	2024-03-18	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	836c4a24-42f6-451a-8911-23444e01e5e8	2024-03-18	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	74a28333-53c1-493e-b6ad-2192fdc35391	2024-03-12	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL SUCCINATE generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATE ER	METOPROLOL SUCCINATE	Direct_Rx	7ea78d2a-aa9f-38d4-e053-2991aa0a07fe	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Direct_Rx	90a69a79-5517-0ccf-e053-2995a90a441f	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL SUCCINATE generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	5fccf8de-d0f7-4ad1-b53f-6c2b1025ba1b	2023-12-14	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.

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