Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsORALGeneric

RAZADYNE ER

GALANTAMINE HYDROBROMIDE

Standard Dose
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview RAZADYNE ER is listed in Drugs@FDA under application 021615 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient GALANTAMINE HYDROBROMIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor JANSSEN PHARMS Submission history Latest submission status date: 2022-09-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview RAZADYNE ER is listed in Drugs@FDA under application 021615 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GALANTAMINE HYDROBROMIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor JANSSEN PHARMS Submission history Latest submission status date: 2022-09-26 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.