Drug application

SUPPRELIN LA (HISTRELIN ACETATE)

Drugs@FDA NDA 022058 · ENDO OPERATIONS

Key facts

Drug name SUPPRELIN LA
Active ingredients HISTRELIN ACETATE
Application type NDA
Application number 022058
Company ENDO OPERATIONS
Dosage forms IMPLANT, SUBCUTANEOUS
Strength 50MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date May 3, 2007

At a glance

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