Drug application

CEVIMELINE HYDROCHLORIDE (CEVIMELINE HYDROCHLORIDE)

Drugs@FDA ANDA 220267 · ZYDUS LIFESCIENCES

Key facts

Drug name CEVIMELINE HYDROCHLORIDE
Active ingredients CEVIMELINE HYDROCHLORIDE
Application type ANDA
Application number 220267
Company ZYDUS LIFESCIENCES
Dosage forms CAPSULE, ORAL
Strength 30MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Mar 11, 2026

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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