Application 206980

Type: ANDA
Sponsor: IPCA LABS LTD

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 43.

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
A206980-001	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25
A206980-002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25
A206980-003	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25
A206980-004	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206980-001	AB
A206980-002	AB
A206980-003	AB
A206980-004	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.

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	A206980-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206980-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206980-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206980-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206980-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206980-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206980-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206980-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206980-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206980-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206980-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206980-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206980-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206980-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206980-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206980-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206980-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206980-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206980-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206980-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206980-001	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206980-002	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206980-003	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206980-004	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-06-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206980-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206980-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206980-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206980-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206980-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206980-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206980-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206980-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206980-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206980-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206980-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206980-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206980-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206980-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206980-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206980-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206980-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206980-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206980-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206980-004	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206980-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206980-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206980-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206980-004	AB	1	`a50c72e98297…`

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 3 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	Aphena Pharma Solutions - Tennessee, LLC	51b630c7-6c03-7876-e063-6294a90acb30	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Redpharm Drug	301ec2ea-84cb-ad89-e063-6294a90af49d	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Ingenus Pharmaceuticals, LLC	9dcd1fdf-a651-48d4-8033-e5749d5f5650	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	ST. MARY'S MEDICAL PARK PHARMACY	4f59e872-8dab-8c35-e063-6294a90a15d5	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Cardinal Health 107, LLC	028049cd-d233-49f9-87fa-ec91e433a49f	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Proficient Rx LP	9bd9ff03-7c11-41c9-9054-126313d10506	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Zhejiang Jutai Pharamceutical Co., Ltd	4df90eca-70e3-5c7c-e063-6294a90adc41	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Major Pharmaceuticals	14ab9921-4651-4abc-92dc-aab1719b6bb0	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
TOPROL XL	METOPROLOL SUCCINATE	Melinta Therapeutics, LLC	496ddfaa-7c9c-4888-b747-a210249b367a	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	NuCare Pharmaceuticals, Inc.	4b1cfb2f-2345-af53-e063-6294a90a4ff0	2026-02-18	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	BluePoint Laboratories	d92dc643-37b1-4d1e-8fc0-cfb27c3e2702	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	NuCare Pharmaceuticals,Inc.	4a900d2c-12d1-6bfa-e063-6294a90af009	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	860e0ee0-b24f-4eff-b196-b9b03b37d3d5	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Coupler LLC	48ec9246-f887-2ed4-e063-6394a90ac952	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Dr. Reddy's Laboratories Inc	24c87741-ee0a-738e-2c5a-5ce80ca2f48b	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Dr. Reddy's Laboratories Inc	5b7095c8-f8b7-adc7-9052-92325da33a02	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	PD-Rx Pharmaceuticals, Inc.	ff3eaf6a-5697-4ad9-98c4-86925e6da257	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	471f154c-197f-31df-e063-6394a90ae73e	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	NuCare Pharmaceuticals, Inc.	47f96afd-1483-66d5-e063-6294a90a201f	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	REMEDYREPACK INC.	874a38ba-667e-47b6-a918-a972c0e3ed59	2026-01-08	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.