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 5 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	114346a1-ce49-49d2-9674-2fa6a49749c3	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	46c288aa-a55c-4207-9a6e-ceef3c2f60ff	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	AvPAK	71b27b55-44aa-113d-e053-2995a90a1cf7	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Cardinal Health 107, LLC	184db12c-0642-4741-a997-cd0b2a5ce337	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Cardinal Health 107, LLC	e2f8dd23-600f-460e-aced-4e13504628f1	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Cardinal Health 107, LLC	1ab032d6-db68-4108-85d1-56e828d0dc01	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Cardinal Health 107, LLC	f6689572-d53d-49eb-a932-85056612a355	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Major Pharmaceuticals	459fe5ce-14d1-4901-956a-b5597ea9016c	2025-08-06	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Dr. Reddy's Laboratories Limited	71c1d33e-be6f-6d59-b715-45075445891a	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Quallent Pharmaceuticals Health LLC	250c2428-c8b0-5156-697a-60cb8a45713c	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Quallent Pharmaceuticals Health LLC	e147a897-4a23-1e1a-73cd-f2e6c9a7280d	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Northstar Rx LLC	ad097646-cc77-8d67-5974-cc00060409f2	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Northstar Rx LLC	d887be8a-e6c2-5129-edbd-d7b2c0283dca	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	5223b690-0ccd-4ec4-b83b-22ce392713b2	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	4da96d34-ae8e-4c63-8ba0-bbeefdc20516	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	REMEDYREPACK INC.	35304060-0965-488d-9e6e-bd1217286ea1	2025-06-27	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	75f6c399-7a55-49a2-a8bb-dec534e37548	2025-06-04	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE ER TABLETS	Ascend Laboratories, LLC	58441cd3-6043-4bb8-adab-1b32a203bfb2	2025-05-29	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate
metoprolol succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	cbc32a80-717b-4cf2-b76a-6d03a3720419	2025-05-21	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Preferred Pharmaceuticals Inc.	21e18c1c-fabb-44a4-a33a-b02a47967d73	2025-04-30	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