Application 077761

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

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 42.

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
A077761-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP		2007-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077761-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077761-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2007-05-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077761-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077761-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077761-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077761-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077761-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077761-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077761-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077761-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077761-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077761-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077761-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077761-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077761-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077761-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077761-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077761-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077761-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077761-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077761-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077761-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077761-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077761-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077761-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077761-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077761-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077761-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077761-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077761-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077761-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077761-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077761-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077761-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077761-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077761-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077761-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077761-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077761-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077761-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077761-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077761-001	AP	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol Tartrate	METOROPROLOL TARTRATE	Civica, Inc.	8dae76a2-32e7-40a2-bb70-9c6380b9b330	2026-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077761 application number: ANDA077761 ndc (product): 72572-420
Metoprolol Tartrate	METOROPROLOL TARTRATE	Hikma Pharmaceuticals USA Inc.	c7ec36bb-bc6f-42de-9974-a50ac13e9410	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077761 application number: ANDA077761 ndc (product): 0143-9660 ndc (product): 0143-9873
Metoprolol Tartrate	METOPROLOL TARTRATE	Medical Purchasing Solutions, LLC	b624095a-d1c1-1ce0-e053-2995a90a0698	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077761 application number: ANDA077761 ndc (product): 71872-7225
Metoprolol Tartrate	METOROPROLOL TARTRATE	Medical Purchasing Solutions, LLC	bfc8834e-1df8-170b-e053-2995a90a28f1	2023-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077761 application number: ANDA077761 ndc (product): 71872-7244

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9660	Metoprolol Tartrate	Metoroprolol Tartrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9660	Metoprolol Tartrate	Metoroprolol Tartrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9873	Metoprolol Tartrate	Metoprolol Tartrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9873	Metoprolol Tartrate	Metoprolol Tartrate	West-Ward Pharmaceuticals Corp	ANDA	Current
71872-7225	Metoprolol Tartrate	Metoprolol Tartrate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7244	Metoprolol Tartrate	Metoroprolol Tartrate	Medical Purchasing Solutions, LLC	ANDA	Current
72572-420	Metoprolol Tartrate	Metoroprolol Tartrate	Civica, Inc.	ANDA	Current
72572-420	Metoprolol Tartrate	Metoroprolol Tartrate	Civica, Inc.	ANDA	Current