Application 018704

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPRESSOR	METOPROLOL TARTRATE	INJECTABLE;INJECTION	1MG/ML	Yes	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
N018704-001	LOPRESSOR	METOPROLOL TARTRATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1984-03-30

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018704-001	LOPRESSOR	1MG/ML	INJECTABLE / INJECTION	RLD	1984-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018704-001	LOPRESSOR	1MG/ML	INJECTABLE / INJECTION	RLD	1984-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018704-001	LOPRESSOR	1MG/ML	INJECTABLE / INJECTION	RLD	1984-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018704-001	LOPRESSOR	1MG/ML	INJECTABLE / INJECTION	RLD	1984-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018704-001	LOPRESSOR	1MG/ML	INJECTABLE / INJECTION	RLD	1984-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018704-001	LOPRESSOR	1MG/ML	INJECTABLE / INJECTION	RLD	1984-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018704-001	LOPRESSOR	1MG/ML	INJECTABLE / INJECTION	RLD	1984-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018704-001	LOPRESSOR	1MG/ML	INJECTABLE / INJECTION	RLD	1984-03-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018704-001	LOPRESSOR	1MG/ML	INJECTABLE / INJECTION	RLD	1984-03-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018704-001	LOPRESSOR	1MG/ML	INJECTABLE / INJECTION	RLD	1984-03-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018704-001	LOPRESSOR	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-30	`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 3 of 8 · 157 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOPROLOL TARTRATE	METOPROLOL TARTRATE	QPharma, Inc.	4dcb79e6-19de-67fb-e063-6294a90afde0	2026-04-10	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Bryant Ranch Prepack	840ac287-cae5-4c07-82d5-546fb04414ef	2026-04-09	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Bryant Ranch Prepack	22f1b399-83ad-4c2e-bb17-c11967a7471e	2026-04-09	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Redpharm Drug	4ce1c1ef-bc9a-1397-e063-6294a90a3bda	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	4cdbfc5d-2572-39b0-e063-6394a90af5f2	2026-03-12	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Legacy Pharmaceutical Packaging, LLC	20cc66c0-a00b-4643-9819-6e0daed51e5f	2026-03-11	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Bryant Ranch Prepack	77fb1898-871f-489f-bc0b-933dd08a9bc4	2026-03-11	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	13b7404f-e16b-5d43-e063-6394a90a3fca	2026-03-05	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Exelan Pharmaceuticals, Inc.	f54b250d-bd15-483b-b191-a664291382c1	2026-02-27	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	A-S Medication Solutions	e1bb16fa-4f72-44bc-bc33-d7653c13f55c	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	A-S Medication Solutions	5b423eba-0a35-41b0-9338-fa4c6f5c6c7f	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol	METOPROLOL TARTRATE	Fresenius Kabi USA, LLC	ccb1a15e-c943-4042-ae46-550bdabfc96b	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	499ce022-12a7-e4e5-e063-6394a90a435a	2026-01-30	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Advagen Pharma Limited	d62a972a-bc45-4582-9701-bed27a1a9e4d	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
LOPRESSOR	METOPROLOL TARTRATE	VALIDUS PHARMACEUTICALS LLC	b5f4fed2-369c-4808-a682-8a5b8cfdbb4f	2026-01-26	Warnings, Adverse reactions	Name fallback brand name: LOPRESSOR generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	18f44ba2-d431-4a73-ac78-83e734fde694	2026-01-16	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Advagen Pharma Limited	a401fe31-d51a-49d9-a062-c9d22088db56	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	d3628f24-8076-4980-a358-8445ef8260f4	2026-01-12	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	3bb62867-cf85-ce6d-e063-6294a90ad17f	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	19678edf-934a-45f3-b5da-94d10e9b3248	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64411	SUPPL	2020-08-25
64410	SUPPL	2020-08-25
64406	SUPPL	2020-08-25
64405	SUPPL	2020-08-25
33565	SUPPL	2013-03-15
1037	SUPPL	2013-03-15
33564	SUPPL	2013-01-02
15104	SUPPL	2012-12-26
15103	SUPPL	2010-01-06
11287	SUPPL	2009-11-23
1036	SUPPL	2008-07-30
33563	SUPPL	2008-07-29
1035	SUPPL	2008-01-09
15102	SUPPL	2006-09-18
1034	SUPPL	2003-09-25