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Orange Book product · Brand (NDA)

ISTALOL

TIMOLOL MALEATE

Brand (NDA)NDA 021516TE AT2RX BAUSCH AND LOMB
View TIMOLOL MALEATE familyOpen on FDA Orange Book

At a glance

Jun 04, 2004

Approved

Brand (NDA)

Application

AT2

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 04, 2004

    22 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TIMOLOL MALEATE

Strength

EQ 0.5% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AT2

Application

NDA 021516

Product number

001

Marketing status

RX

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.

Agent CTA Background

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