Drug application

CINACALCET HYDROCHLORIDE (CINACALCET HYDROCHLORIDE)

Drugs@FDA ANDA 208971 · ZYDUS PHARMS USA INC

Key facts

Drug name CINACALCET HYDROCHLORIDE
Active ingredients CINACALCET HYDROCHLORIDE
Application type ANDA
Application number 208971
Company ZYDUS PHARMS USA INC
Dosage forms TABLET, ORAL
Strength EQ 30MG BASE
Marketing status None (Tentative Approval)
TE codes AB
Reference listed drug No
Latest submission status date Nov 26, 2018

At a glance

  • 1–9 Submissions
  • 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

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