Orange Book product

TROPICACYL 0.5%

Orange Book ANDA 040314 · EPIC PHARMA LLC · Prescription

Key facts

Proprietary name TROPICACYL
Active ingredients TROPICAMIDE
Strength 0.5%
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application ANDA040314
Applicant holder EPIC PHARMA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 29, 2000

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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