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Last Updated: November 4, 2024

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. Thirteen 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

Profile for product number 001

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4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Profile for product number 002

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8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Profile for product number 003

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12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Expired US Patents for NDA 021169

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-002 Feb 28, 2001 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 Feb 28, 2001 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-001 Feb 28, 2001 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 Feb 28, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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