Application Nr Approved Date Route Status External Links
ANDA078926 2011-02-11 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Gabapentin Tablets, Usp Are Indicated For: Postherpetic Neuralgia In Adults ( 1) Adjunctive Therapy In The Treatment Of Partial Onset Seizures, With And Without Secondary Generalization, In Adults And Pediatric Patients 3 Years And Older With Epilepsy ( 1) Gabapentin Tablets, Usp Are Indicated For: Management Of Postherpetic Neuralgia In Adults Adjunctive Therapy In The Treatment Of Partial Onset Seizures, With And Without Secondary Generalization, In Adults And Pediatric Patients 3 Years And Older With Epilepsy

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Copovidone K25-31 COPOVIDONE K25-31 Unresolved
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.
3. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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