Orange Book product · Brand (NDA)

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OLOPATADINE HYDROCHLORIDE

Brand (NDA)NDA 020688OTC ALCON LABS INC

View OLOPATADINE HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Dec 18, 1996

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 18, 1996
29 yr 11 mo ago
Today

Pharmaceutical detail

Active ingredient

OLOPATADINE HYDROCHLORIDE

Strength

EQ 0.1% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 020688

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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