Orange Book product · Brand (NDA)

ADASUVE

LOXAPINE

Brand (NDA)NDA 022549RX NOVA PNEUMA

Dec 21, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 21, 2012
13 yr 8 mo ago
Today
Patent 8387612 expires
Listed drug product patent expiration.
Oct 23, 2026
in 4 mo

Active ingredient

LOXAPINE

Strength

10MG

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 022549

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
8387612	Oct 23, 2026	in 4 mo	Product