Drug application

DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)

Drugs@FDA ANDA 216968 · ALEMBIC

Key facts

Drug name DILTIAZEM HYDROCHLORIDE
Active ingredients DILTIAZEM HYDROCHLORIDE
Application type ANDA
Application number 216968
Company ALEMBIC
Dosage forms CAPSULE, EXTENDED RELEASE, ORAL
Strength 120MG
Marketing status Prescription
TE codes AB3
Reference listed drug No
Latest submission status date Nov 8, 2024

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 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

Browse all Drugs@FDA applications