Orange Book product · Brand (NDA)

LIKMEZ

METRONIDAZOLE

Brand (NDA)NDA 216755RX SAPTALIS PHARMS

Sep 22, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 22, 2023
2 yr 9 mo ago
Today
Patent 12257236 expires
Listed drug product patent expiration.
Jan 16, 2039
in 12 yr 9 mo
Patent 12257236 expires
Listed drug product patent expiration.
Jan 16, 2039
in 12 yr 9 mo
Patent 12257236 expires
Listed drug product patent expiration.
Jan 16, 2039
in 12 yr 9 mo
Patent 11541035 expires
Listed drug product patent expiration.
Oct 04, 2039
in 13 yr 6 mo

Active ingredient

METRONIDAZOLE

Strength

500MG/5ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 216755

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
12257236	Jan 16, 2039	in 12 yr 9 mo	ProductU-3169
12257236	Jan 16, 2039	in 12 yr 9 mo	ProductU-4163
12257236	Jan 16, 2039	in 12 yr 9 mo	ProductU-4164
11541035	Oct 04, 2039	in 13 yr 6 mo	Product