Drug application

EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)

Drugs@FDA ANDA 040765 · AMNEAL PHARMS NY

Key facts

Drug name EXTENDED PHENYTOIN SODIUM
Active ingredients PHENYTOIN SODIUM
Application type ANDA
Application number 040765
Company AMNEAL PHARMS NY
Dosage forms CAPSULE, ORAL
Strength 100MG EXTENDED
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Nov 12, 2008

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 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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