Application 203028

Type: ANDA
Sponsor: PHARMADAX 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 25MG TARTRATE	No	No
002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG 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
A203028-001	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB		2020-03-31
A203028-002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB		2020-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203028-001	AB
A203028-002	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 2 · 78 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	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203028-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203028-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203028-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203028-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203028-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203028-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203028-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203028-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203028-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203028-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203028-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203028-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203028-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203028-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203028-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203028-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203028-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203028-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203028-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203028-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203028-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203028-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203028-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203028-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203028-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203028-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203028-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203028-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203028-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203028-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203028-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203028-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203028-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203028-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203028-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203028-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203028-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203028-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203028-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203028-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203028-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203028-002	AB	1	`bb7c543d1eb4…`

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 6 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	NuCare Pharmaceutcals, Inc.	32341a31-a2db-cf13-e063-6394a90aad89	2025-04-07	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	e602c70f-9ea3-480f-a7df-15f23c6b3307	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	28ca1918-c220-41b3-9e58-a0a023f775d0	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	8ed15c20-23a2-40ba-95e8-2689d182a52f	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	01908d20-0e16-4410-bd27-1b6df162ede4	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE	Cranbury Pharmaceuticals, LLC	8b8cae90-e02a-4a99-81ff-37629c9a4243	2025-03-30	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	89e642f6-5f8c-4352-8da6-7b74ed4ff23c	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	8d812b11-c9ec-470e-a108-70d86403e473	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	2ef668c8-7279-4f61-b6af-9c4ccb3b90d0	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	dbb4cadc-5af0-4ff5-ab6c-8bf1b68b700c	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	afa6c1f5-0c8e-496f-930a-1ade1f69646b	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	123f2051-4bff-4621-aaba-65f54f4e7784	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	d1bbf535-8b02-4d99-bb4d-2e87454c1d61	2025-03-27	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	52496331-174e-4ae3-9763-6b9a4072befd	2025-03-27	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE	PD-Rx Pharmaceuticals, Inc.	4d8cdd8b-3896-4cd0-9570-a6f4e1d340d7	2025-03-18	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	NCS HealthCare of KY, LLC dba Vangard Labs	c4fb991c-025c-4a1d-9766-4b62ad70b5fe	2025-02-19	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Proficient Rx LP	e29d6ea1-1374-4572-ad7e-b0c2ea48ca04	2025-02-01	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Epic Pharma, LLC	2c70177a-615b-4ed7-a58f-a298212e8fae	2025-01-24	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Redpharm Drug	0b25ce23-6d78-bc88-e063-6294a90abb78	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Oryza Pharmaceuticals, Inc	6cfe96df-bd75-432d-b2c2-e26143ca36dd	2025-01-09	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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60050-001	Metoprolol Succinate	Metoprolol Succinate	Pharmadax Inc.	ANDA	Current
60050-002	Metoprolol Succinate	Metoprolol Succinate	Pharmadax Inc.	ANDA	Current
64679-846	Metoprolol Succinate	Metoprolol Succinate	Wockhardt USA LLC.	ANDA	Current
64679-846	Metoprolol Succinate	Metoprolol Succinate	Wockhardt USA LLC.	ANDA	Current
64679-847	Metoprolol Succinate	Metoprolol Succinate	Wockhardt USA LLC.	ANDA	Current
64679-847	Metoprolol Succinate	Metoprolol Succinate	Wockhardt USA LLC.	ANDA	Current
75834-290	Metoprolol Succinate	Metoprolol Succinate	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-291	Metoprolol Succinate	Metoprolol Succinate	Nivagen Pharmaceuticals, Inc.	ANDA	Current