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Orange Book product · Brand (NDA)

ISOPTO ATROPINE

ATROPINE SULFATE

Brand (NDA)NDA 208151TE AT2RX ALCON LABS INC
View ATROPINE SULFATE familyOpen on FDA Orange Book

At a glance

Dec 01, 2016

Approved

Brand (NDA)

Application

AT2

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 01, 2016

    9 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ATROPINE SULFATE

Strength

1%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AT2

Application

NDA 208151

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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