Application 022083

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXELON	RIVASTIGMINE	FILM, EXTENDED RELEASE;TRANSDERMAL	4.6MG/24HR	Yes	No
002	EXELON	RIVASTIGMINE	FILM, EXTENDED RELEASE;TRANSDERMAL	9.5MG/24HR	Yes	Yes
005	EXELON	RIVASTIGMINE	FILM, EXTENDED RELEASE;TRANSDERMAL	13.3MG/24HR	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022083-001	EXELON	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06
N022083-002	EXELON	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06
N022083-005	EXELON	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N022083-001	AB
N022083-002	AB
N022083-005	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 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022083-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022083-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022083-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022083-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022083-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022083-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022083-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022083-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022083-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022083-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022083-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022083-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022083-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022083-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022083-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022083-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022083-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022083-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022083-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022083-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022083-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022083-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022083-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022083-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022083-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022083-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022083-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022083-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022083-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022083-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022083-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022083-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022083-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022083-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022083-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022083-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022083-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022083-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022083-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022083-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022083-001	6316023	2019-01-08	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022083-001	6335031	2019-01-08	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022083-002	6316023	2019-01-08	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022083-002	6335031	2019-01-08	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022083-005	6316023	2019-01-08	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022083-005	6335031	2019-01-08	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022083-001	6316023	2019-01-08	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022083-001	6335031	2019-01-08	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022083-002	6316023	2019-01-08	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022083-002	6335031	2019-01-08	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022083-005	6316023	2019-01-08	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022083-005	6335031	2019-01-08	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022083-001	6316023	2019-01-08	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022083-001	6335031	2019-01-08	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022083-002	6316023	2019-01-08	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022083-002	6335031	2019-01-08	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022083-005	6316023	2019-01-08	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022083-005	6335031	2019-01-08	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022083-001	6316023	2019-01-08	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022083-001	6335031	2019-01-08	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022083-002	6316023	2019-01-08	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022083-002	6335031	2019-01-08	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022083-005	6316023	2019-01-08	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022083-005	6335031	2019-01-08	Drug product	`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
Rivastigmine	RIVASTIGMINE	Sandoz Inc	92a58ebb-748d-49f4-bf11-ecbcf5424152	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022083 application number: NDA022083 ndc (product): 0781-7313 ndc (product): 0781-7304 ndc (product): 0781-7309
Exelon	RIVASTIGMINE	Novartis Pharmaceuticals Corporation	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022083 application number: NDA022083 ndc (product): 0078-0501 ndc (product): 0078-0502 ndc (product): 0078-0503
Exelon	RIVASTIGMINE	Sandoz Inc	b6ed6d15-116d-4596-92ce-3414574d7ba0	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022083 application number: NDA022083

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0501	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0501	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0501	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0501	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0501	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0501	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0502	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0502	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0502	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0502	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0502	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0502	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0503	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0503	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0503	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0503	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0503	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0503	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0781-7304	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7304	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7304	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7309	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7309	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7309	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7313	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7313	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7313	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
21695-357	Exelon	rivastigmine	Rebel Distributors Corp	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78457	SUPPL	2024-05-14
78443	SUPPL	2024-05-09
56933	SUPPL	2018-12-21
56798	SUPPL	2018-12-19
45806	SUPPL	2016-11-04
45801	SUPPL	2016-11-03
45790	SUPPL	2016-11-02
29221	SUPPL	2015-02-05
16919	SUPPL	2015-02-05
38206	SUPPL	2013-07-11
6851	SUPPL	2013-07-01
16918	SUPPL	2012-09-06
6850	SUPPL	2012-09-05
16917	SUPPL	2010-09-07
6849	SUPPL	2010-08-31
42410	ORIG	2009-05-28
16916	ORIG	2007-07-09