Zonisamide

Product NDC

0378-6727

11-digit product format

003786727

Labeler code

0378

Product ID

0378-6727_2cf3045b-a102-4257-8f94-0971aa729d12

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

zonisamide

Dosage form

CAPSULE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA077637

Marketing category

ANDA

Marketing start

2005-12-23

Marketing end

2019-12-31

Substance

ZONISAMIDE

Active strength

100 mg/1

Pharmacologic classes

Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record