Assyro AI

Orange Book product · Generic (ANDA)

TROPICACYL

TROPICAMIDE

Generic (ANDA)ANDA 040314TE ATRX EPIC PHARMA LLC

At a glance

Sep 29, 2000

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 29, 2000

    26 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TROPICAMIDE

Strength

0.5%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AT

Application

ANDA 040314

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TROPICAMIDE

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.