Last Updated: September 24, 2026

Details for New Drug Application (NDA): 215445

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NDA 215445 describes RIVASTIGMINE, which is a drug marketed by Alvogen, Amneal Pharms, Breckenridge, Mylan Technologies, Yichang Humanwell, Zydus Pharms, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orbion Pharms, Sun Pharm, and Watson Labs, and is included in sixteen NDAs. It is available from seven suppliers. Additional details are available on the RIVASTIGMINE profile page.

The generic ingredient in RIVASTIGMINE is rivastigmine tartrate. There are two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.

Summary for 215445

Tradename:	RIVASTIGMINE
Applicant:	Yichang Humanwell
Ingredient:	rivastigmine
Patents:	0

Medical Subject Heading (MeSH) Categories for 215445

Cholinesterase Inhibitors
Neuroprotective Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	4.6MG/24HR
Approval Date:	Sep 23, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	9.5MG/24HR
Approval Date:	Sep 23, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	13.3MG/24HR
Approval Date:	Sep 23, 2025	TE:	AB	RLD:	No

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