Application 213854

Type: ANDA
Sponsor: YICHANG HUMANWELL

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
003	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG TARTRATE	No	No
004	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213854-001	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12
A213854-002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12
A213854-003	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-11-08
A213854-004	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A213854-001	AB
A213854-002	AB
A213854-003	AB
A213854-004	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 4 · 128 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	A213854-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213854-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213854-003	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213854-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213854-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213854-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213854-003	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213854-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213854-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213854-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213854-003	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213854-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213854-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213854-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213854-003	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213854-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213854-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213854-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213854-003	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213854-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213854-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213854-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213854-003	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213854-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213854-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213854-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213854-003	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213854-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213854-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213854-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213854-003	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213854-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213854-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213854-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213854-003	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213854-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213854-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213854-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-02-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213854-003	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213854-004	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-01	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213854-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213854-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213854-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213854-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213854-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213854-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213854-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213854-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213854-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213854-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213854-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213854-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213854-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213854-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213854-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213854-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213854-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213854-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213854-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213854-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213854-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213854-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213854-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213854-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213854-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213854-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213854-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213854-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213854-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213854-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213854-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213854-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213854-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213854-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213854-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213854-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213854-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213854-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213854-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213854-004	AB	1	`d06236e962d9…`

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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol succinate	METOPROLOL SUCCINATE	ST. MARY'S MEDICAL PARK PHARMACY	4136f1e3-b8f4-cb6c-e063-6294a90a03c2	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213854 application number: ANDA213854
Metoprolol succinate	METOPROLOL SUCCINATE	ST. MARY'S MEDICAL PARK PHARMACY	4f59e872-8dab-8c35-e063-6294a90a15d5	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213854 application number: ANDA213854
Metoprolol Succinate	METOPROLOL SUCCINATE	BluePoint Laboratories	d92dc643-37b1-4d1e-8fc0-cfb27c3e2702	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213854 application number: ANDA213854
Metoprolol succinate	METOPROLOL SUCCINATE	Coupler LLC	48ec9246-f887-2ed4-e063-6394a90ac952	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213854 application number: ANDA213854
Metoprolol succinate	METOPROLOL SUCCINATE	REMEDYREPACK INC.	874a38ba-667e-47b6-a918-a972c0e3ed59	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213854 application number: ANDA213854
Metoprolol succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	f80b420c-cc9a-a051-e053-6294a90a8ed9	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213854 application number: ANDA213854
Metoprolol succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	fa160cd3-4349-8e94-e053-6394a90a5887	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213854 application number: ANDA213854
Metoprolol succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	fa16cb4e-d70a-d07f-e053-6294a90a9512	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213854 application number: ANDA213854
Metoprolol succinate	METOPROLOL SUCCINATE	Epic Pharma, LLC	2c70177a-615b-4ed7-a58f-a298212e8fae	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213854 application number: ANDA213854
Metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	6103540c-93b5-46e8-9ef3-5059fa0335ab	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213854 application number: ANDA213854
Metoprolol succinate	METOPROLOL SUCCINATE	Slate Run Pharmaceuticals, LLC	c00f99e2-7a88-6f9b-e053-2995a90a6ace	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213854 application number: ANDA213854 ndc (product): 70436-166 ndc (product): 70436-202 ndc (product): 70436-183 ndc (product): 70436-167
Metoprolol succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	e780699f-d795-44ce-9828-a0caa6283fb3	2023-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213854 application number: ANDA213854 ndc (product): 50090-6260

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6260	Metoprolol succinate	Metoprolol succinate	A-S Medication Solutions	ANDA	Current
62732-1046	Metoprolol succinate	Metoprolol succinate	Yichang Humanwell Pharmaceutical Co., Ltd.	ANDA	Current
62732-1047	Metoprolol succinate	Metoprolol succinate	Yichang Humanwell Pharmaceutical Co., Ltd.	ANDA	Current
70436-166	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-166	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-166	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-166	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-166	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-167	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-167	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-167	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-167	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-167	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-183	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-183	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-183	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-202	Metoprolol succinate	Metoprolol succinate	Slate Run Pharmaceuticals, LLC	ANDA	Current