Application 205541

Type: ANDA
Sponsor: HETERO LABS LTD III

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
003	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG TARTRATE	No	No
004	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG 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
A205541-001	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06
A205541-002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06
A205541-003	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06
A205541-004	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205541-001	AB
A205541-002	AB
A205541-003	AB
A205541-004	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 · 144 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	A205541-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205541-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205541-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205541-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205541-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205541-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205541-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205541-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205541-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205541-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205541-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205541-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205541-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205541-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205541-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205541-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205541-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205541-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205541-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205541-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205541-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205541-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205541-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205541-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205541-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205541-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205541-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205541-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205541-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205541-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205541-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205541-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205541-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205541-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205541-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205541-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205541-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205541-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205541-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205541-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-06	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 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	A205541-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205541-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205541-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205541-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205541-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205541-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205541-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205541-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205541-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205541-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205541-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205541-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205541-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205541-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205541-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205541-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205541-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205541-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205541-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205541-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205541-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205541-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205541-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205541-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205541-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205541-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205541-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205541-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205541-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205541-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205541-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205541-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205541-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205541-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205541-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205541-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205541-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205541-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205541-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205541-004	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	74a28333-53c1-493e-b6ad-2192fdc35391	2024-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205541 application number: ANDA205541 ndc (product): 31722-592 ndc (product): 31722-590 ndc (product): 31722-589 ndc (product): 31722-591
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Proficient Rx LP	09fa1b7f-1911-4bc2-825b-c885a44f5c63	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205541 application number: ANDA205541 ndc (product): 71205-724
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Proficient Rx LP	411ed6c7-c5e0-446c-9745-9095404dd0f6	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205541 application number: ANDA205541 ndc (product): 71205-683

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-589	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-589	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-589	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-590	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-590	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-590	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-591	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-591	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-591	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-592	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-592	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-592	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-5950	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	A-S Medication Solutions	ANDA	Current
50090-6097	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	A-S Medication Solutions	ANDA	Current
71205-683	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Proficient Rx LP	ANDA	Current
71205-724	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Proficient Rx LP	ANDA	Current