Drug application

GABAPENTIN (GABAPENTIN)

Drugs@FDA ANDA 075435 · TEVA PHARMS

Key facts

Drug name GABAPENTIN
Active ingredients GABAPENTIN
Application type ANDA
Application number 075435
Company TEVA PHARMS
Dosage forms CAPSULE, ORAL
Strength 100MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Oct 8, 2004

At a glance

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