Application Nr Approved Date Route Status External Links
ANDA078218 2015-06-19 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Cyclobenzaprine Hydrochloride Is Indicated As An Adjunct To Rest And Physical Therapy For Relief Of Muscle Spasm Associated With Acute, Painful Musculoskeletal Conditions. Improvement Is Manifested By Relief Of Muscle Spasm And Its Associated Signs And Symptoms, Namely, Pain, Tenderness, Limitation Of Motion, And Restriction In Activities Of Daily Living. Cyclobenzaprine Hydrochloride Should Be Used Only For Short Periods (up To Two Or Three Weeks) Because Adequate Evidence Of Effectiveness For More Prolonged Use Is Not Available And Because Muscle Spasm Associated With Acute, Painful Musculoskeletal Conditions Is Generally Of Short Duration And Specific Therapy For Longer Periods Is Seldom Warranted. Cyclobenzaprine Hydrochloride Has Not Been Found Effective In The Treatment Of Spasticity Associated With Cerebral Or Spinal Cord Disease, Or In Children With Cerebral Palsy.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
8. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
9. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE ZINC968263