Orange Book product · Brand (NDA)

TOBI PODHALER

TOBRAMYCIN

Brand (NDA)NDA 201688RX VIATRIS

Mar 22, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 22, 2013
13 yr 5 mo ago
Today
Patent 8869794 expires
Listed drug product patent expiration.
Sep 12, 2028
in 2 yr 3 mo
Patent 10207066 expires
Listed drug product patent expiration.
Nov 04, 2030
in 4 yr 5 mo

Active ingredient

TOBRAMYCIN

Strength

28MG

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 201688

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
8869794	Sep 12, 2028	in 2 yr 3 mo	ProductU-909
10207066	Nov 04, 2030	in 4 yr 5 mo	ProductU-909