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 2 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	Bryant Ranch Prepack	9c33fc53-35d1-4b01-a805-ae737405db3f	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Preferred Pharmaceuticals Inc	0ded3105-b962-4748-bf5b-fca7a4557562	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	6da0e3dc-1b11-4975-b35c-5a6ca13cf990	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Preferred Pharmaceuticals Inc.	7dfe56fe-68b6-4897-9238-0f530c92e27e	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL SUCCINATE generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	d58b56cc-1a3d-4147-afc2-12e8236c3766	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Northwind Health Company, LLC	471bca3e-3401-6814-e063-6394a90a9cb1	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	REMEDYREPACK INC.	c2eb2a77-761a-49c0-9eca-8eb57d8532d2	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Cardinal Health 107, LLC	450fb603-73d7-422b-a4e2-5a05c13ebe3b	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	St. Mary's Medical Park Pharmacy	0a99ed82-2ee8-6f9c-e063-6394a90ac7ba	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	ST. MARY'S MEDICAL PARK PHARMACY	4136f1e3-b8f4-cb6c-e063-6294a90a03c2	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	St Mary's Medical Park Pharmacy	cdb69427-0489-3751-e053-2995a90a3667	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Proficient Rx LP	d7f6200f-d600-4a13-9434-b77f99057ae8	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Golden State Medical Supply, Inc.	bd0b68cc-3a7e-2223-e053-2995a90ac8f6	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	REMEDYREPACK INC.	ea67ed64-47df-4728-8e62-c5d7316a71aa	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	REMEDYREPACK INC.	eea82ccb-876b-4fe8-9270-dcea509029a5	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	7689f30e-4010-4d7f-b450-9bc181259495	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol Succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	a3aadb05-74e1-4c73-906c-be64f5242d36	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Zydus Pharmaceuticals (USA) Inc.	bd77ec6e-c58c-440b-81d6-8a462b2fdc9c	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
Metoprolol succinate	METOPROLOL SUCCINATE	Aphena Pharma Solutions - Tennessee, LLC	522c40f2-80f1-e2fc-e063-6294a90ad091	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE
metoprolol succinate	METOPROLOL SUCCINATE	Zydus Lifesciences Limited	1098f26d-8319-4dba-ad66-3df22db2b399	2026-05-19	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.