Orange Book product

OPTOMYCIN 0.5%

Orange Book ANDA 062171 · OPTOPICS LABORATORIES CORP · Discontinued

Key facts

Proprietary name OPTOMYCIN
Active ingredients CHLORAMPHENICOL
Strength 0.5%
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application ANDA062171
Applicant holder OPTOPICS LABORATORIES CORP
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 31, 1982

At a glance

  • None 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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