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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204403

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NDA 204403 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 thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.

Summary for 204403

Tradename:	RIVASTIGMINE
Applicant:	Alvogen
Ingredient:	rivastigmine
Patents:	0

Medical Subject Heading (MeSH) Categories for 204403

Cholinesterase Inhibitors
Neuroprotective Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	4.6MG/24HR
Approval Date:	Sep 3, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	9.5MG/24HR
Approval Date:	Sep 3, 2015	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	13.3MG/24HR
Approval Date:	Aug 31, 2015	TE:		RLD:	No

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