Application 090317

Type: ANDA
Sponsor: MYLAN ASI

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 1.

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
A090317-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION			2010-04-19

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2010-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2010-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2010-04-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2010-04-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2010-04-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2010-04-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090317-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		2010-04-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090317-001	AP	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A090317-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090317-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090317-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090317-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090317-001	AP	1	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOPROLOL	METOPROLOL TARTRATE INJECTION	Oneosource Specialty Pharma Limited	05946833-9d66-4832-a0d8-b91b1ff01b8b	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090317 application number: ANDA090317