Drug application

PEG 3350 AND ELECTROLYTES (POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE and 2 more)

Drugs@FDA ANDA 090186 · NOVEL LABS INC

Key facts

Drug name PEG 3350 AND ELECTROLYTES
Active ingredients POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS
Application type ANDA
Application number 090186
Company NOVEL LABS INC
Dosage forms FOR SOLUTION, ORAL
Strength 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT
Marketing status Prescription
TE codes AA
Reference listed drug No
Latest submission status date Jun 1, 2009

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

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

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