Orange Book product

NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

Orange Book ANDA 062714 · ALCON PHARMACEUTICALS LTD · Discontinued

Key facts

Proprietary name NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE
Active ingredients DEXAMETHASONE SODIUM PHOSPHATE, NEOMYCIN SULFATE
Strength EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application ANDA062714
Applicant holder ALCON PHARMACEUTICALS LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 21, 1986

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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