Application 091307

Type: ANDA
Sponsor: LUITPOLD

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
A091307-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION			2010-12-29

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091307-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2010-12-29	`f41ea6bd6efb…`

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 9 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	Proficient Rx LP	a3209878-e763-4a53-9c2b-ad39535f385c	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Proficient Rx LP	c5c8ca26-d3dd-46ba-bf04-6aae9f334445	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Proficient Rx LP	d4c8f068-7410-4543-9a66-7f4c19ff63a5	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	ea141b60-b08e-4f0f-9f29-cd765f4d7ca6	2022-03-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Gland Pharma Limited	e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe	2020-10-08	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	991b445a-8cdc-4b99-bfd4-7da833f3f5c7	2020-06-04	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Bryant Ranch Prepack	7e9e5e82-10fa-4e9b-b57c-3ec85b05c046	2019-06-11	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	5b0286d3-d00e-43cb-9172-efd37801596f	2018-11-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	b31ddfe3-bbcd-468a-92a8-1f0ccb3e8879	2018-11-08	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	b60d2cb0-f2c3-4ad5-8060-5179d5b94256	2018-09-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	97d32bcd-92f7-4c8e-877d-acc355a2350d	2018-07-07	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.