Drug application

ROSUVASTATIN ZINC (ROSUVASTATIN ZINC)

Drugs@FDA NDA 202172 · WATSON LABS INC

Key facts

Drug name ROSUVASTATIN ZINC
Active ingredients ROSUVASTATIN ZINC
Application type NDA
Application number 202172
Company WATSON LABS INC
Dosage forms TABLET, ORAL
Strength 5MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission class Type 2 - New Active Ingredient
Latest submission status date Feb 12, 2016

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None 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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