Felbatol

Treats partial seizures, with and without generalization. NDA 20189, held by Mylan Speciality LP. Felbamate.

As of Nov 13, 2026, NDA 20189 (Felbatol), held by Mylan Speciality LP, was first approved by FDA on Jul 29, 1993, with 16 approved supplements and 0 published complete response letters.

First approved: Jul 29, 1993
Review: Priority
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Felbatol is not indicated as a first line antiepileptic treatment (see Warnings ). Felbatol is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jul 29, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Felbatol400MG · tablet;oral	Felbamate	RxReference drug
Felbatol600MG · tablet;oral	Felbamate	RxReference drug
Felbatol600MG/5ML · suspension;oral	Felbamate	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 31, 2012	Supplement 27Labeling · Standard review	Approved	Label Medication Guide Letter
Jul 6, 2011	Supplement 23Labeling · Standard review	Approved	Letter Label
Apr 23, 2009	Supplement 22Labeling	Approved	Label Letter
Nov 19, 2002	Supplement 18Labeling · Standard review	Approved	Letter
Jun 26, 2002	Supplement 19Manufacturing · Priority review	Approved	None posted
Aug 28, 1995	Supplement 12Manufacturing · Priority review	Approved	None posted
Jun 26, 1995	Supplement 11Manufacturing · Priority review	Approved	None posted
Jan 24, 1995	Supplement 10Manufacturing · Priority review	Approved	None posted
Nov 29, 1994	Supplement 9Labeling · Standard review	Approved	None posted
Nov 1, 1994	Supplement 8Labeling · Standard review	Approved	None posted
Nov 1, 1994	Supplement 6Labeling · Standard review	Approved	None posted
May 31, 1994	Supplement 5Manufacturing · Priority review	Approved	None posted
Mar 2, 1994	Supplement 4Labeling · Standard review	Approved	None posted
Dec 21, 1993	Supplement 3Manufacturing · Priority review	Approved	None posted
Dec 20, 1993	Supplement 2Manufacturing · Priority review	Approved	None posted
Sep 17, 1993	Supplement 1Manufacturing · Priority review	Approved	None posted
Jul 29, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20189
Drugs@FDA: Overview at FDA
Company: Mylan Specialty

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters