Clozapine

Product NDC

51079-212

11-digit product format

510790212

Labeler code

51079

Product ID

51079-212_7babd349-f24f-9815-e053-2a91aa0a22ae

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

clozapine

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA201824

Marketing category

ANDA

Marketing start

2017-03-23

Marketing end

0000-00-00

Substance

CLOZAPINE

Active strength

25 mg/1

Pharmacologic classes

Atypical Antipsychotic [EPC]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record