Orange Book product · Brand (NDA)

PATADAY ONCE DAILY RELIEF

OLOPATADINE HYDROCHLORIDE

Brand (NDA)NDA 206276OTC ALCON LABS INC

Jan 30, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 30, 2015
11 yr 7 mo ago
Today
Patent 8791154 expires
Listed drug product patent expiration.
May 19, 2032
in 6 yr
Patent 9533053 expires
Listed drug product patent expiration.
May 19, 2032
in 6 yr

Active ingredient

OLOPATADINE HYDROCHLORIDE

Strength

EQ 0.7% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 206276

Product number

001

Marketing status

OTC

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
8791154	May 19, 2032	in 6 yr	ProductU-1680
9533053	May 19, 2032	in 6 yr	Product