Orange Book product

POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL

Orange Book ANDA 078915 · MYLAN PHARMACEUTICALS INC · Over the counter

Key facts

Proprietary name POLYETHYLENE GLYCOL 3350
Active ingredients POLYETHYLENE GLYCOL 3350
Strength 17GM/SCOOPFUL
Dosage form FOR SOLUTION
Route ORAL
Application ANDA078915
Applicant holder MYLAN PHARMACEUTICALS INC
Marketing status Over the counter
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 6, 2009

At a glance

  • 10–99 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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