Orange Book product

NEURONTIN 800MG

Orange Book NDA 020882 · VIATRIS SPECIALTY LLC · Prescription

Key facts

Proprietary name NEURONTIN
Active ingredients GABAPENTIN
Strength 800MG
Dosage form TABLET
Route ORAL
Application NDA020882
Applicant holder VIATRIS SPECIALTY LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB1
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Oct 9, 1998

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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