Drug application

CEVIMELINE HYDROCHLORIDE (CEVIMELINE HYDROCHLORIDE)

Drugs@FDA ANDA 091260 · APOTEX INC

Key facts

Drug name CEVIMELINE HYDROCHLORIDE
Active ingredients CEVIMELINE HYDROCHLORIDE
Application type ANDA
Application number 091260
Company APOTEX INC
Dosage forms CAPSULE, ORAL
Strength 30MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Aug 25, 2011

At a glance

  • 1–9 Submissions
  • 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:

Browse all Drugs@FDA applications