Drug application

POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350)

Drugs@FDA ANDA 091077 · NOVEL LABS INC

Key facts

Drug name POLYETHYLENE GLYCOL 3350
Active ingredients POLYETHYLENE GLYCOL 3350
Application type ANDA
Application number 091077
Company NOVEL LABS INC
Dosage forms FOR SOLUTION, ORAL
Strength 17GM/SCOOPFUL
Marketing status Over-the-counter
Reference listed drug No
Latest submission status date Oct 6, 2009

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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