Application 020823

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	EXELON	RIVASTIGMINE TARTRATE	CAPSULE;ORAL	EQ 1.5MG BASE	Yes	No
004	EXELON	RIVASTIGMINE TARTRATE	CAPSULE;ORAL	EQ 3MG BASE	Yes	No
005	EXELON	RIVASTIGMINE TARTRATE	CAPSULE;ORAL	EQ 4.5MG BASE	Yes	No
006	EXELON	RIVASTIGMINE TARTRATE	CAPSULE;ORAL	EQ 6MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
N020823-003	EXELON	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21
N020823-004	EXELON	RIVASTIGMINE TARTRATE	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21
N020823-005	EXELON	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21
N020823-006	EXELON	RIVASTIGMINE TARTRATE	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020823-003	EXELON	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020823-004	EXELON	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020823-005	EXELON	EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020823-006	EXELON	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020823-003	EXELON	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020823-004	EXELON	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020823-005	EXELON	EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020823-006	EXELON	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020823-003	EXELON	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020823-004	EXELON	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020823-005	EXELON	EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020823-006	EXELON	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020823-003	EXELON	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020823-004	EXELON	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020823-005	EXELON	EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020823-006	EXELON	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020823-003	EXELON	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020823-004	EXELON	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020823-005	EXELON	EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020823-006	EXELON	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020823-003	EXELON	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020823-004	EXELON	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020823-005	EXELON	EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020823-006	EXELON	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020823-003	EXELON	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020823-004	EXELON	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020823-005	EXELON	EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020823-006	EXELON	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020823-003	EXELON	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020823-004	EXELON	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020823-005	EXELON	EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020823-006	EXELON	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020823-003	EXELON	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020823-004	EXELON	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020823-005	EXELON	EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020823-006	EXELON	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020823-003	EXELON	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020823-004	EXELON	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020823-005	EXELON	EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020823-006	EXELON	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-04-21	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N020823-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020823-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020823-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020823-006	AB	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 · 14 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	Nivagen Pharmaceuticals, Inc.	83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a1	2022-02-16	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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0323	Exelon	rivastigmine tartrate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0324	Exelon	rivastigmine tartrate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0325	Exelon	rivastigmine tartrate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0326	Exelon	rivastigmine tartrate	Novartis Pharmaceuticals Corporation	NDA	Current
0781-2614	Rivastigmine Tartrate	rivastigmine tartrate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2615	Rivastigmine Tartrate	rivastigmine tartrate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2616	Rivastigmine Tartrate	rivastigmine tartrate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2617	Rivastigmine Tartrate	rivastigmine tartrate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56930	SUPPL	2018-12-21
56795	SUPPL	2018-12-19
45808	SUPPL	2016-11-04
45799	SUPPL	2016-11-03
35420	SUPPL	2015-02-05
35419	SUPPL	2013-10-08
35418	SUPPL	2013-10-08
35417	SUPPL	2013-10-08
13494	SUPPL	2013-10-08
25921	SUPPL	2013-10-04
25920	SUPPL	2013-10-04
3430	SUPPL	2013-10-04
3426	SUPPL	2013-10-04
20981	SUPPL	2007-06-18
3429	SUPPL	2006-07-03
13493	SUPPL	2006-06-28
20982	SUPPL	2006-06-27
3428	SUPPL	2004-09-24
3427	SUPPL	2004-05-07
13492	SUPPL	2001-01-05
20980	ORIG	2000-04-21
13491	ORIG	2000-04-21
3425	ORIG	2000-04-21