Application 076495

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	INJECTABLE;INJECTION	1MG/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076495-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP		2003-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076495-001	AP

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 2 · 43 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	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076495-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-07-07	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A076495-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076495-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076495-001	AP	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 1 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	0ca72c89-82c5-4b31-b515-1a8b8e82ec59	2026-09-10	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	621249c4-531b-4138-9bde-77a06ad7816b	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Redpharm Drug	59ed1885-cc00-5325-e063-6294a90a50c2	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	Redpharm Drug	59ed27b8-32b5-60c0-e063-6394a90a8a23	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	REMEDYREPACK INC.	58d493d3-b69c-422a-b6a8-0f8fa1e55545	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	Northwind Health Company, LLC	106b7a0c-af7f-2565-e063-6294a90a34e0	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	cbcec1e7-7eac-456e-a253-aaf6761b4883	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	REMEDYREPACK INC.	c9ccdbc0-0e4e-40c4-aacf-de60deda9fd5	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	REMEDYREPACK INC.	3a236293-35c1-4083-9805-ab40df535083	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	58239cf1-53b4-4ef7-e063-6394a90a65bd	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Proficient Rx LP	4871791a-7679-4345-8fd6-fdb9c9217352	2026-08-01	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Cardinal Health 107, LLC	6399f2c3-7799-4f8b-b8b7-8d2137b1f852	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	REMEDYREPACK INC.	028b6e4a-1597-4d21-89d0-0bbbad21efa8	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	Bryant Ranch Prepack	00940cc5-d2eb-4841-9138-de97d7b1c674	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	Northwind Health Company, LLC	471ccbfe-96dd-7ab9-e063-6394a90a5bd6	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	5476c4fc-ab09-ee1a-e063-6394a90a7a1b	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Cardinal Health 107, LLC	0ccb9d3c-3f9a-486d-9b27-dc6f3ef6f4ed	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Safecor Health, LLC	63d45147-9b37-40e2-9619-cd1a3e77ff31	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Bryant Ranch Prepack	a590edb1-3310-49e3-b3d1-dbbb3f81f1c1	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	American Health Packaging	0a3ccfd4-8b65-4c7e-b0ba-27ff40d5b5e8	2026-07-02	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.