Application 207465

Type: ANDA
Sponsor: CIPLA

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 50MG TARTRATE	No	No
002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG TARTRATE	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207465-001	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26
A207465-002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26
A207465-003	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207465-001	AB
A207465-002	AB
A207465-003	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 · 123 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	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A207465-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207465-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207465-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207465-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207465-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207465-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207465-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207465-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207465-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207465-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207465-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207465-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207465-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207465-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207465-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207465-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207465-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207465-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207465-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207465-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207465-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207465-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207465-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207465-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207465-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207465-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207465-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207465-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207465-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207465-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207465-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207465-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207465-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207465-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207465-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207465-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207465-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207465-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207465-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207465-001	AB	1	`8072bd15b7f6…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Coupler LLC	55f20cc3-d958-bd74-e063-6394a90a7850	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Preferred Pharmaceuticals Inc.	7dfe56fe-68b6-4897-9238-0f530c92e27e	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465 ndc (product): 68788-8312
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	NuCare Pharmaceuticals,Inc.	a849d489-8f8c-18e6-e053-2995a90a3770	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465 ndc (product): 68071-5282
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	A-S Medication Solutions	91e401fe-ec92-494e-9966-35c280f23efa	2023-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	A-S Medication Solutions	820a962a-5b15-4beb-bd78-e1ac10cb2e0e	2023-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	BluePoint Laboratories	6a4f2446-a9e4-479a-87bd-2d5539dcded9	2023-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465 ndc (product): 68001-469 ndc (product): 68001-471 ndc (product): 68001-470
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Bryant Ranch Prepack	5bf27a6c-ea3f-425e-9cfc-a5a308e2af1c	2023-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Cipla USA Inc.	3a4966a2-2728-4c99-999f-576b3e2df90c	2023-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465 ndc (product): 69097-408 ndc (product): 69097-407 ndc (product): 69097-409

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68001-469	METOPROLOL SUCCINATE	metoprolol succinate	BluePoint Laboratories	ANDA	Current
68001-469	METOPROLOL SUCCINATE	metoprolol succinate	BluePoint Laboratories	ANDA	Current
68001-469	METOPROLOL SUCCINATE	metoprolol succinate	BluePoint Laboratories	ANDA	Current
68001-470	METOPROLOL SUCCINATE	metoprolol succinate	BluePoint Laboratories	ANDA	Current
68001-470	METOPROLOL SUCCINATE	metoprolol succinate	BluePoint Laboratories	ANDA	Current
68001-470	METOPROLOL SUCCINATE	metoprolol succinate	BluePoint Laboratories	ANDA	Current
68001-471	METOPROLOL SUCCINATE	metoprolol succinate	BluePoint Laboratories	ANDA	Current
68001-471	METOPROLOL SUCCINATE	metoprolol succinate	BluePoint Laboratories	ANDA	Current
68071-2455	METOPROLOL SUCCINATE	metoprolol succinate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5282	METOPROLOL SUCCINATE	metoprolol succinate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5282	METOPROLOL SUCCINATE	metoprolol succinate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8312	METOPROLOL SUCCINATE	metoprolol succinate	Preferred Pharmaceuticals Inc.	ANDA	Current
69097-407	METOPROLOL SUCCINATE	metoprolol succinate	Cipla USA Inc.	ANDA	Current
69097-407	METOPROLOL SUCCINATE	metoprolol succinate	Cipla USA Inc.	ANDA	Current
69097-407	METOPROLOL SUCCINATE	metoprolol succinate	Cipla USA Inc.	ANDA	Current
69097-408	METOPROLOL SUCCINATE	metoprolol succinate	Cipla USA Inc.	ANDA	Current
69097-408	METOPROLOL SUCCINATE	metoprolol succinate	Cipla USA Inc.	ANDA	Current
69097-408	METOPROLOL SUCCINATE	metoprolol succinate	Cipla USA Inc.	ANDA	Current
69097-409	METOPROLOL SUCCINATE	metoprolol succinate	Cipla USA Inc.	ANDA	Current
69097-409	METOPROLOL SUCCINATE	metoprolol succinate	Cipla USA Inc.	ANDA	Current
69097-409	METOPROLOL SUCCINATE	metoprolol succinate	Cipla USA Inc.	ANDA	Current
70518-2868	METOPROLOL SUCCINATE	metoprolol succinate	REMEDYREPACK INC.	ANDA	Current
70518-2868	METOPROLOL SUCCINATE	metoprolol succinate	REMEDYREPACK INC.	ANDA	Current