Application 017963

Type: NDA
Sponsor: US PHARMS HOLDINGS I

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017963-001	LOPRESSOR	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017963-002	LOPRESSOR	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N017963-001	AB
N017963-002	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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N017963-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017963-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017963-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017963-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017963-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017963-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017963-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017963-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017963-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017963-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017963-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017963-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017963-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017963-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017963-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017963-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017963-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017963-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017963-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017963-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017963-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017963-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017963-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017963-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017963-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017963-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017963-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017963-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017963-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017963-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017963-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017963-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017963-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017963-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017963-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017963-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017963-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017963-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017963-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017963-002	AB	1	`4b0b4de00fa7…`

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
Lopressor	METOPROLOL TARTRATE	Validus Pharmaceuticals LLC	0283bc9d-6998-493a-824a-d4c85f704111	2023-09-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017963 application number: NDA017963 ndc (product): 30698-459 ndc (product): 30698-458

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30698-458	Lopressor	metoprolol tartrate	Validus Pharmaceuticals LLC	NDA	Current
30698-458	Lopressor	metoprolol tartrate	Validus Pharmaceuticals LLC	NDA	Current
30698-459	Lopressor	metoprolol tartrate	Validus Pharmaceuticals LLC	NDA	Current
30698-459	Lopressor	metoprolol tartrate	Validus Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77141	SUPPL	2024-01-04
77175	SUPPL	2024-01-03
74711	SUPPL	2023-07-07
74705	SUPPL	2023-07-06
13967	SUPPL	2013-03-15
11100	SUPPL	2013-03-15
11099	SUPPL	2013-01-11
761	SUPPL	2012-12-26
33379	SUPPL	2011-03-21
760	SUPPL	2010-01-06
33378	SUPPL	2009-11-23
759	SUPPL	2008-07-30
33377	SUPPL	2008-07-29
13966	SUPPL	2008-01-09
758	SUPPL	2006-09-18
13965	SUPPL	2003-09-25