Orange Book product · Brand (NDA)

KARBINAL ER

CARBINOXAMINE MALEATE

Brand (NDA)NDA 022556RX AYTU

Mar 28, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 28, 2013
13 yr 5 mo ago
Today
Patent 9522191 expires
Listed drug product patent expiration.
Jun 15, 2027
in 1 yr
Patent 8062667 expires
Listed drug product patent expiration.
Mar 29, 2029
in 2 yr 10 mo

Active ingredient

CARBINOXAMINE MALEATE

Strength

4MG/5ML

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 022556

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
9522191	Jun 15, 2027	in 1 yr	Product
8062667	Mar 29, 2029	in 2 yr 10 mo	Product