Orange Book product

LACTULOSE 10GM/15ML

Orange Book ANDA 075993 · LANNETT CO INC · Prescription

Key facts

Proprietary name LACTULOSE
Active ingredients LACTULOSE
Strength 10GM/15ML
Dosage form SOLUTION
Route ORAL
Application ANDA075993
Applicant holder LANNETT CO INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 26, 2001

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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