Orange Book product · Brand (NDA)

PLIAGLIS

LIDOCAINE; TETRACAINE

Brand (NDA)NDA 021717RX CRESCITA THERAP

Jun 29, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 29, 2006
20 yr 3 mo ago
Today
Patent 10350180 expires
Listed drug product patent expiration.
Jan 14, 2031
in 4 yr 8 mo
Patent 10603293 expires
Listed drug product patent expiration.
Jan 14, 2031
in 4 yr 8 mo
Patent 10751305 expires
Listed drug product patent expiration.
Jan 14, 2031
in 4 yr 8 mo
Patent 12558328 expires
Listed method-of-use patent (U-4421) expiration.
Jan 14, 2031
in 4 yr 8 mo

Active ingredient

LIDOCAINE; TETRACAINE

Strength

7%;7%

Dosage form

CREAM

Route

TOPICAL

TE code

Not listed

Application

NDA 021717

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
10350180	Jan 14, 2031	in 4 yr 8 mo	Product
10603293	Jan 14, 2031	in 4 yr 8 mo	Product
10751305	Jan 14, 2031	in 4 yr 8 mo	Product
12558328	Jan 14, 2031	in 4 yr 8 mo	U-4421