Application 078459

Type: ANDA
Sponsor: IPCA LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	25MG	No	No
002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	50MG	No	No
003	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078459-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17
A078459-002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17
A078459-003	METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078459-001	AB
A078459-002	AB
A078459-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078459-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078459-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078459-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078459-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078459-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078459-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078459-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078459-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078459-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078459-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078459-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078459-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078459-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078459-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078459-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078459-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078459-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078459-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078459-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078459-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078459-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078459-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078459-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078459-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078459-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078459-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078459-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078459-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078459-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078459-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078459-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078459-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078459-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078459-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078459-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078459-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078459-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078459-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078459-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078459-001	AB	1	`301d65b070ca…`

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 4 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol	METOPROLOL TARTRATE	Fresenius Kabi USA, LLC	ccb1a15e-c943-4042-ae46-550bdabfc96b	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	499ce022-12a7-e4e5-e063-6394a90a435a	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Advagen Pharma Limited	d62a972a-bc45-4582-9701-bed27a1a9e4d	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
LOPRESSOR	METOPROLOL TARTRATE	VALIDUS PHARMACEUTICALS LLC	b5f4fed2-369c-4808-a682-8a5b8cfdbb4f	2026-01-26	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	18f44ba2-d431-4a73-ac78-83e734fde694	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Advagen Pharma Limited	a401fe31-d51a-49d9-a062-c9d22088db56	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	d3628f24-8076-4980-a358-8445ef8260f4	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	3bb62867-cf85-ce6d-e063-6294a90ad17f	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	19678edf-934a-45f3-b5da-94d10e9b3248	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	NuCare Pharmaceuticals, Inc.	47d11c0c-82dd-33b1-e063-6394a90a6a97	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	NuCare Pharmaceuticals, Inc.	47d18ba7-558d-1190-e063-6294a90a958f	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	e07d2929-7f78-cf63-e053-2995a90af82b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	f318d14a-9f96-4238-e053-2995a90abc15	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	f319e981-81ff-22da-e053-2a95a90a2738	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	d9cbda2a-70d9-74d3-e053-2a95a90aacc1	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	d9df7d01-339c-8985-e053-2a95a90a0d2c	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Proficient Rx LP	0c8e58ab-c755-4560-b7f5-0dbd5e81a0b8	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Coupler LLC	4616db7f-2c2f-96a5-e063-6394a90a939f	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	NuCare Pharmaceuticals, Inc.	4604cd40-f96f-42bf-e063-6294a90a308f	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	QPharma Inc	2ad0606c-7a90-44bd-a75d-d256de30fbcf	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50436-3155	Metoprolol Tartrate	Metoprolol Tartrate	Unit Dose Services	ANDA	Current
50436-6578	Metoprolol Tartrate	Metoprolol Tartrate	Unit Dose Services	ANDA	Current
53808-1018	Metoprolol Tartrate	Metoprolol Tartrate	State of Florida DOH Central Pharmacy	ANDA	Current
63304-579	Metoprolol Tartrate	Metoprolol Tartrate	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-580	Metoprolol Tartrate	Metoprolol Tartrate	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-581	Metoprolol Tartrate	Metoprolol Tartrate	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63629-1462	Metoprolol Tartrate	Metoprolol Tartrate	Bryant Ranch Prepack	ANDA	Current
64725-0579	Metoprolol Tartrate	Metoprolol Tartrate	TYA Pharmaceuticals	ANDA	Current
67046-473	Metoprolol tartrate	metoprolol tartrate	Contract Pharmacy Services-PA	ANDA	Current
67046-474	Metoprolol Tartrate	Metoprolol tartrate	Contract Pharmacy Services-PA	ANDA	Current
68788-9686	Metoprolol Tartrate	Metoprolol Tartrate	Preferred Pharmaceuticals, Inc.	ANDA	Current