Orange Book product · Brand (NDA)

ULTRAVATE

HALOBETASOL PROPIONATE

Brand (NDA)NDA 208183RX LACER PHARMA

Nov 06, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 06, 2015
10 yr 9 mo ago
Today
Patent 8962028 expires
Listed drug product patent expiration.
Jun 19, 2033
in 7 yr 1 mo

Active ingredient

HALOBETASOL PROPIONATE

Strength

0.05%

Dosage form

LOTION

Route

TOPICAL

TE code

Not listed

Application

NDA 208183

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
8962028	Jun 19, 2033	in 7 yr 1 mo	ProductU-1775