Application Nr Approved Date Route Status External Links
ANDA077068 2005-08-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Baclofen Is Useful For The Alleviation Of Signs And Symptoms Of Spasticity Resulting From Multiple Sclerosis, Particularly For The Relief Of Flexor Spasms And Concomitant Pain, Clonus, And Muscular Rigidity. Patients Should Have Reversible Spasticity So That Baclofen Treatment Will Aid In Restoring Residual Function. Baclofen May Also Be Of Some Value In Patients With Spinal Cord Injuries And Other Spinal Cord Diseases. Baclofen Is Not Indicated In The Treatment Of Skeletal Muscle Spasm Resulting From Rheumatic Disorders. The Efficacy Of Baclofen In Stroke, Cerebral Palsy, And Parkinson's Disease Has Not Been Established And, Therefore, It Is Not Recommended For These Conditions.

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Baclofen BACLOFEN ZINC61