Application Nr Approved Date Route Status External Links
ANDA077272 2005-12-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Epilepsy Carbamazepine Is Indicated For Use As An Anticonvulsant Drug. Evidence Supporting Efficacy Of Carbamazepine As An Anticonvulsant Was Derived From Active Drug-Controlled Studies That Enrolled Patients With The Following Seizure Types: Partial Seizures With Complex Symptomatology (psychomotor, Temporal Lobe). Patients With These Seizures Appear To Show Greater Improvement Than Those With Other Types. Generalized Tonic-Clonic Seizures (grand Mal). Mixed Seizure Patterns Which Include The Above, Or Other Partial Or Generalized Seizures. Absence Seizures (petit Mal) Do Not Appear To Be Controlled By Carbamazepine (see Precautions, General). Trigeminal Neuralgia Carbamazepine Is Indicated In The Treatment Of The Pain Associated With True Trigeminal Neuralgia. Beneficial Results Have Also Been Reported In Glossopharyngeal Neuralgia. This Drug Is Not A Simple Analgesic And Should Not Be Used For The Relief Of Trivial Aches Or Pains.

All Formulated Excipients (4 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. Hypromelloses HYPROMELLOSES Unresolved
3. 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.
4. Starch, Corn STARCH, CORN Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Carbamazepine CARBAMAZEPINE ZINC4785

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