Drug application

TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE (ESTRADIOL VALERATE, TESTOSTERONE ENANTHATE)

Drugs@FDA ANDA 085865 · WATSON LABS

Key facts

Drug name TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE
Active ingredients ESTRADIOL VALERATE, TESTOSTERONE ENANTHATE
Application type ANDA
Application number 085865
Company WATSON LABS
Dosage forms INJECTABLE, INJECTION
Strength 4MG/ML;90MG/ML
Marketing status Discontinued
Reference listed drug No
Latest submission status date May 7, 1981

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • No FDA letters on file
  • Yes 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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