Orange Book product · Brand (NDA)

ACZONE

DAPSONE

Brand (NDA)NDA 207154TE ABRX ALMIRALL

Feb 24, 2016

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 24, 2016
10 yr 6 mo ago
Today
Patent 11273132 expires
Listed drug product patent expiration.
Nov 18, 2033
in 7 yr 6 mo

Active ingredient

DAPSONE

Strength

7.5%

Dosage form

GEL

Route

TOPICAL

TE code

Application

NDA 207154

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
11273132	Nov 18, 2033	in 7 yr 6 mo	Product