Drug application

METOCLOPRAMIDE HYDROCHLORIDE (METOCLOPRAMIDE HYDROCHLORIDE)

Drugs@FDA ANDA 202191 · NOVEL LABS INC

Key facts

Drug name METOCLOPRAMIDE HYDROCHLORIDE
Active ingredients METOCLOPRAMIDE HYDROCHLORIDE
Application type ANDA
Application number 202191
Company NOVEL LABS INC
Dosage forms TABLET, ORALLY DISINTEGRATING, ORAL
Strength EQ 5MG BASE
Marketing status Prescription
Reference listed drug No
Latest submission status date Aug 15, 2014

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None 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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