Application Nr Approved Date Route Status External Links
ANDA075350 2003-09-12 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Postherpetic Neuralgia Gabapentin Is Indicated For The Management Of Postherpetic Neuralgia In Adults. Epilepsy Gabapentin Is Indicated As Adjunctive Therapy In The Treatment Of Partial Seizures With And Without Secondary Generalization In Patients Over 12 Years Of Age With Epilepsy. Gabapentin Is Also Indicated As Adjunctive Therapy In The Treatment Of Partial Seizures In Pediatric Patients Age 3 To 12 Years.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Gelatin GELATIN Unresolved
3. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
4. Shellac SHELLAC Unresolved
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
7. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Gabapentin GABAPENTIN ZINC1554010

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