Details for New Drug Application (NDA): 021169

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NDA 021169 describes RAZADYNE, which is a drug marketed by Janssen Pharms and is included in three NDAs. Additional details are available on the RAZADYNE profile page.

The generic ingredient in RAZADYNE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.

Summary for 021169

Tradename:	RAZADYNE
Applicant:	Janssen Pharms
Ingredient:	galantamine hydrobromide
Patents:	0

Medical Subject Heading (MeSH) Categories for 021169

Cholinesterase Inhibitors
Nootropic Agents
Parasympathomimetics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 28, 2001	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 28, 2001	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 28, 2001	TE:		RLD:	Yes

Expired US Patents for NDA 021169

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001	6,099,863	⤷ Get Started Free
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-001	Feb 28, 2001	4,663,318	⤷ Get Started Free
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-002	Feb 28, 2001	6,099,863	⤷ Get Started Free
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-002	Feb 28, 2001	6,358,527	⤷ Get Started Free
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001	4,663,318	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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