Drug application

ESTRADIOL (ESTRADIOL)

Drugs@FDA ANDA 216055 · AMNEAL

Key facts

Drug name ESTRADIOL
Active ingredients ESTRADIOL
Application type ANDA
Application number 216055
Company AMNEAL
Dosage forms GEL, TRANSDERMAL
Strength 0.1% (0.25GM/PACKET)
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jul 12, 2024

At a glance

  • 1–9 Submissions
  • 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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