Orange Book product · Brand (NDA)

TETRACAINE HYDROCHLORIDE

Brand (NDA)NDA 210821TE AB1RX BAUSCH LOMB IRELAND

View TETRACAINE HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Mar 12, 2019

Approved

Brand (NDA)

Application

AB1

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Mar 12, 2019
7 yr 5 mo ago
Today

Pharmaceutical detail

Active ingredient

TETRACAINE HYDROCHLORIDE

Strength

0.5%

Dosage form

SOLUTION

Route

OPHTHALMIC

TE code

AB1

Application

NDA 210821

Product number

001

Marketing status

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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