Drug application

ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)

Drugs@FDA ANDA 205519 · SCIEGEN PHARMS

Key facts

Drug name ATORVASTATIN CALCIUM
Active ingredients ATORVASTATIN CALCIUM
Application type ANDA
Application number 205519
Company SCIEGEN PHARMS
Dosage forms TABLET, ORAL
Strength EQ 10MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date May 19, 2016

At a glance

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

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