Felbamate

Product NDC

70710-1053

11-digit product format

707101053

Labeler code

70710

Product ID

70710-1053_1cefb345-60f6-49be-a166-b394750783ae

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Felbamate

Dosage form

TABLET

Route

ORAL

Labeler

Zydus Pharmaceuticals (USA) Inc.

Application

ANDA208970

Marketing category

ANDA

Marketing start

2017-08-15

Marketing end

0000-00-00

Substance

FELBAMATE

Active strength

400 mg/1

Pharmacologic classes

Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record