Orange Book product

PORTALAC 10GM/15ML

Orange Book ANDA 072374 · SOLVAY PHARMACEUTICALS · Discontinued

Key facts

Proprietary name PORTALAC
Active ingredients LACTULOSE
Strength 10GM/15ML
Dosage form SOLUTION
Route ORAL, RECTAL
Application ANDA072374
Applicant holder SOLVAY PHARMACEUTICALS
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 22, 1989

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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