FazaClo

Product NDC

18860-106

11-digit product format

188600106

Labeler code

18860

Product ID

18860-106_313e175e-dd63-4ba7-b0d7-c0837a5c08a8

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

clozapine

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

Labeler

Jazz Pharmaceuticals, Inc.

Application

NDA021590

Marketing category

NDA

Marketing start

2010-07-09

Marketing end

2020-08-31

Substance

CLOZAPINE

Active strength

200 mg/1

Pharmacologic classes

Atypical Antipsychotic [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record