Drug application

SIROLIMUS (SIROLIMUS)

Drugs@FDA ANDA 201676 · ZYDUS PHARMS

Key facts

Drug name SIROLIMUS
Active ingredients SIROLIMUS
Application type ANDA
Application number 201676
Company ZYDUS PHARMS
Dosage forms TABLET, ORAL
Strength 1MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Feb 15, 2023

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 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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