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Active ingredient

Felbamate

22 finished FDA listings contain Felbamate as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
FELBAMATE
Dosage forms
Suspension, Tablet
Routes
Oral
Manufacturers / labelers
10
Strengths listed
400 mg/1 · 600 mg/1 · 600 mg/5ml
Brand names in FDA listings
Felbatol

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 24812

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020189MYLAN SPECIALITY LP1993-07-292
ANDA 201680AMNEAL PHARMS2011-09-134
ANDA 202385AMNEAL PHARMS2011-12-161
ANDA 202284ANI PHARMS2015-11-046
ANDA 207093TARO2017-04-202
ANDA 208970ZYDUS LIFESCIENCES2017-05-304
ANDA 206314TARO2017-06-162
ANDA 211333NOVITIUM PHARMA2019-05-311

Official labeling on DailyMed

Showing the 12 most recent of 15 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.