Application 019786

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPRESSOR	METOPROLOL FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG TARTRATE	No	No
002	LOPRESSOR	METOPROLOL FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG TARTRATE	No	No
003	LOPRESSOR	METOPROLOL FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 300MG TARTRATE	No	No
004	LOPRESSOR	METOPROLOL FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 400MG TARTRATE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N019786-001	LOPRESSOR	METOPROLOL FUMARATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27
N019786-002	LOPRESSOR	METOPROLOL FUMARATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27
N019786-003	LOPRESSOR	METOPROLOL FUMARATE	EQ 300MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27
N019786-004	LOPRESSOR	METOPROLOL FUMARATE	EQ 400MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019786-001	LOPRESSOR	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019786-002	LOPRESSOR	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019786-003	LOPRESSOR	EQ 300MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019786-004	LOPRESSOR	EQ 400MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019786-001	LOPRESSOR	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019786-002	LOPRESSOR	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019786-003	LOPRESSOR	EQ 300MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019786-004	LOPRESSOR	EQ 400MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019786-001	LOPRESSOR	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019786-002	LOPRESSOR	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019786-003	LOPRESSOR	EQ 300MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019786-004	LOPRESSOR	EQ 400MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019786-001	LOPRESSOR	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019786-002	LOPRESSOR	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019786-003	LOPRESSOR	EQ 300MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019786-004	LOPRESSOR	EQ 400MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019786-001	LOPRESSOR	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019786-002	LOPRESSOR	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019786-003	LOPRESSOR	EQ 300MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019786-004	LOPRESSOR	EQ 400MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019786-001	LOPRESSOR	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019786-002	LOPRESSOR	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019786-003	LOPRESSOR	EQ 300MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019786-004	LOPRESSOR	EQ 400MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019786-001	LOPRESSOR	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019786-002	LOPRESSOR	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019786-003	LOPRESSOR	EQ 300MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019786-004	LOPRESSOR	EQ 400MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019786-001	LOPRESSOR	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019786-002	LOPRESSOR	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019786-003	LOPRESSOR	EQ 300MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019786-004	LOPRESSOR	EQ 400MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019786-001	LOPRESSOR	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019786-002	LOPRESSOR	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019786-003	LOPRESSOR	EQ 300MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019786-004	LOPRESSOR	EQ 400MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019786-001	LOPRESSOR	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019786-002	LOPRESSOR	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019786-003	LOPRESSOR	EQ 300MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019786-004	LOPRESSOR	EQ 400MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	1989-12-27	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOPRESSOR	METOPROLOL TARTRATE	VALIDUS PHARMACEUTICALS LLC	b5f4fed2-369c-4808-a682-8a5b8cfdbb4f	2026-01-26	Warnings, Adverse reactions	Name fallback brand name: LOPRESSOR
LOPRESSOR	METOPROLOL TARTRATE	VALIDUS PHARMACEUTICALS LLC	9f448171-9588-4a54-88b3-5d870060ce86	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: LOPRESSOR
Lopressor	METOPROLOL TARTRATE	Validus Pharmaceuticals LLC	0283bc9d-6998-493a-824a-d4c85f704111	2023-09-14	Warnings, Adverse reactions	Name fallback brand name: Lopressor

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.