Drug application

AVIANE-28 (ETHINYL ESTRADIOL, LEVONORGESTREL)

Drugs@FDA ANDA 075796 · DURAMED PHARMS BARR

Key facts

Drug name AVIANE-28
Active ingredients ETHINYL ESTRADIOL, LEVONORGESTREL
Application type ANDA
Application number 075796
Company DURAMED PHARMS BARR
Dosage forms TABLET, ORAL-28
Strength 0.02MG;0.1MG
Marketing status Prescription
TE codes AB1
Reference listed drug No
Latest submission status date Apr 30, 2001

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents
  • Yes 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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