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

BACLOFEN

BACLOFEN

Standard Dose
0.05MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BACLOFEN is listed in Drugs@FDA under application 210777 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BACLOFEN Form and strength INJECTABLE;INTRATHECAL - 0.05MG/ML Sponsor MAIA PHARMS INC Submission history Latest submission status date: 2021-01-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview BACLOFEN is listed in Drugs@FDA under application 210777 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BACLOFEN Form and strength INJECTABLE;INTRATHECAL - 0.05MG/ML Sponsor MAIA PHARMS INC Submission history Latest submission status date: 2021-01-15 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.