Orange Book product

NEO-SYNALAR 0.025%;EQ 3.5MG BASE/GM

Orange Book ANDA 060700 · EUROFARMA INC · Prescription

Key facts

Proprietary name NEO-SYNALAR
Active ingredients FLUOCINOLONE ACETONIDE, NEOMYCIN SULFATE
Strength 0.025%;EQ 3.5MG BASE/GM
Dosage form CREAM
Route TOPICAL
Application ANDA060700
Applicant holder EUROFARMA INC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jan 1, 1982

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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