Application 215445

Type: ANDA
Sponsor: YICHANG HUMANWELL

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A215445-001	RIVASTIGMINE	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23
A215445-002	RIVASTIGMINE	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23
A215445-003	RIVASTIGMINE	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215445-001	AB
A215445-002	AB
A215445-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215445-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215445-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215445-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215445-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215445-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215445-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215445-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215445-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215445-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215445-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215445-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215445-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215445-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215445-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215445-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2025-09-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215445-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215445-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215445-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215445-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215445-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215445-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215445-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215445-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215445-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215445-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215445-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215445-003	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215445-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215445-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215445-003	AB	1	`a50c72e98297…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rivastigmine	RIVASTIGMINE	Zydus Lifesciences Limited	966d59ea-5cea-4fef-8b96-e0efe885caf4	2025-11-17		Name fallback brand name: Rivastigmine generic name: RIVASTIGMINE
Rivastigmine	RIVASTIGMINE	Northstar Rx LLC.	8b809739-8381-4cc1-ab4a-5b17ab902a3d	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine generic name: RIVASTIGMINE
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	8d8823c0-9339-4ec8-8a19-d13974b6614b	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	a7f9328e-b6da-4474-ac93-3cdd4825e163	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	5cd5c434-ffd0-4aed-9eba-145c86b115bb	2025-03-27	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	a68d70c9-19f2-47db-bf78-4da04a87a702	2025-03-20	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	6cc286d9-c5d4-4505-83bb-9015e3077851	2025-03-19	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE
Rivastigmine Transdermal System	RIVASTIGMINE	Breckenridge Pharmaceutical, Inc.	b201fe68-b5e5-4a6f-8cf1-069543f03e76	2025-01-15	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	1ebeb8ec-5348-4bb1-ab3d-834690351094	2024-12-24	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE
Rivastigmine	RIVASTIGMINE	Mylan Pharmaceuticals Inc.	4ab335d1-19ee-4cd9-9776-8086645d19e4	2024-09-21	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine generic name: RIVASTIGMINE
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	82630f84-fb47-47ab-8ee2-1720a486de02	2024-08-19	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE
Rivastigmine	RIVASTIGMINE	Amneal Pharmaceuticals LLC	8b671fc9-8cb0-4406-a9ee-7c95086d6200	2024-07-02	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine generic name: RIVASTIGMINE
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	c569f760-f311-42ba-909c-a36319622b35	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE
Rivastigmine	RIVASTIGMINE	Zydus Pharmaceuticals USA Inc.	64dad603-2389-456b-8c18-d1d40b7e7419	2024-05-27	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine generic name: RIVASTIGMINE
Rivastigmine	RIVASTIGMINE	Sandoz Inc	92a58ebb-748d-49f4-bf11-ecbcf5424152	2024-05-08	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine generic name: RIVASTIGMINE
Exelon	RIVASTIGMINE	Novartis Pharmaceuticals Corporation	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	2024-05-08	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE
Exelon	RIVASTIGMINE	Sandoz Inc	b6ed6d15-116d-4596-92ce-3414574d7ba0	2024-05-08	Warnings, Adverse reactions	Name fallback generic name: RIVASTIGMINE

Reported adverse events (FAERS/openFDA)#

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