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 4 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	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
Metoprolol Succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	47202157-3f32-275d-e063-6294a90a5c44	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	BluePoint Laboratories	99ecc717-38ab-4d00-8bf2-86a41b1c7977	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	05d8ebd3-d6ad-434c-8788-985d50a2abfd	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Bryant Ranch Prepack	38429f45-5dc7-4455-840c-dee48f60d95b	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Proficient Rx LP	33d39ddc-478a-4d98-80d1-f655202192ae	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
Metoprolol Succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	57e12147-af06-421a-a2d6-99f0a0ce2b0e	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	PD-Rx Pharmaceuticals, Inc.	4eea76dd-af6d-419a-90e4-ba9eff3b2c73	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	8b77b979-292c-43a0-a739-8ba028d5457c	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	PD-Rx Pharmaceuticals, Inc.	947f7982-2aea-40fb-a93b-c0a28f89da85	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	PD-Rx Pharmaceuticals, Inc.	189b6a89-8de8-4a62-a54b-a6c52be870ca	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	5d553160-7fcb-413a-8775-c128a1844977	2025-09-11	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Preferred Pharmaceuticals Inc.	27bb8bd5-b3ae-4eb3-b508-5684904408be	2025-09-05	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