Orange Book product · Brand (NDA)

VERSACLOZ

CLOZAPINE

Brand (NDA)NDA 203479RX DOUGLAS PHARMS

Feb 06, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 06, 2013
13 yr 7 mo ago
Today
Patent 8057811 expires
Listed drug product patent expiration.
May 01, 2028
in 1 yr 11 mo

Active ingredient

CLOZAPINE

Strength

50MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 203479

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8057811	May 01, 2028	in 1 yr 11 mo	Product