Assyro AI

Orange Book product · Brand (NDA)

ATROPEN

ATROPINE

Brand (NDA)NDA 017106DISCN MMT

At a glance

Sep 17, 2004

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 17, 2004

    22 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ATROPINE

Strength

EQ 0.25MG SULFATE/0.3ML

Dosage form

SOLUTION

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 017106

Product number

004

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.