Application 021025

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXELON	RIVASTIGMINE TARTRATE	SOLUTION;ORAL	EQ 2MG BASE/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
N021025-001	EXELON	RIVASTIGMINE TARTRATE	EQ 2MG BASE/ML	SOLUTION / ORAL		RLD	2000-04-21

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	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL	RLD	2000-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021025-001	EXELON	EQ 2MG BASE/ML	SOLUTION / ORAL		2000-04-21	`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 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	American Health Packaging	52781229-ee82-43f9-a113-4419a611978d	2025-11-11	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Major Pharmaceuticals	39aadc39-0f4f-44f7-88de-83a0ea2ac332	2025-03-03	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Aurobindo Pharma Limited	c246a0e5-1e77-41ee-a7b3-384f21f2f2e0	2024-06-19	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE TARTRATE
Exelon	RIVASTIGMINE	Novartis Pharmaceuticals Corporation	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	2024-05-08	Warnings, Adverse reactions	Name fallback brand name: Exelon
Exelon	RIVASTIGMINE	Sandoz Inc	b6ed6d15-116d-4596-92ce-3414574d7ba0	2024-05-08	Warnings, Adverse reactions	Name fallback brand name: Exelon
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Chartwell RX, LLC	2bb5e0d6-f677-4021-9888-3ff90979ef7d	2023-10-06	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Alembic Pharmaceuticals Limited	33e6a772-382d-45f5-9d45-966c07759367	2023-01-16	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Cadila Pharmaceuticals Limited	e7e641fe-39bd-4681-a430-6dedeb6d6af5	2022-12-29	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Modavar Pharmaceuticals LLC	209f3b02-0acf-46e9-b355-91c918a20eb3	2022-12-28	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE TARTRATE
RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	Macleods Pharmaceuticals Limited	4364f6ef-a8da-4805-be0d-aabbe8ca2d21	2022-08-24	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Alembic Pharmaceuticals Inc.	0044f1d7-613c-4611-8481-13032c8cb390	2022-03-21	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Sun Pharmaceutical Industries, Inc.	bac9ca81-db70-41aa-82af-6c5bb8496846	2019-01-31	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Dr. Reddy's Laboratories Limited	0e20124c-725a-0145-996c-2ff908703162	2019-01-23	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE 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
56929	SUPPL	2018-12-21
56794	SUPPL	2018-12-19
45807	SUPPL	2016-11-04
45800	SUPPL	2016-11-03
35922	SUPPL	2015-02-05
4083	SUPPL	2015-02-05
35921	SUPPL	2013-10-08
35920	SUPPL	2013-10-08
14194	SUPPL	2013-10-08
26523	SUPPL	2013-10-04
4082	SUPPL	2013-10-04
4081	SUPPL	2013-10-04
21358	SUPPL	2007-06-18
26522	SUPPL	2006-07-03
35919	SUPPL	2006-06-28
21359	SUPPL	2006-06-27
4080	SUPPL	2004-09-24
26521	SUPPL	2004-05-07
41886	ORIG	2000-04-21
35918	ORIG	2000-04-21
4079	ORIG	2000-04-21