Drug application

DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)

Drugs@FDA ANDA 207901 · TRIS PHARMA INC

Key facts

Drug name DEXMETHYLPHENIDATE HYDROCHLORIDE
Active ingredients DEXMETHYLPHENIDATE HYDROCHLORIDE
Application type ANDA
Application number 207901
Company TRIS PHARMA INC
Dosage forms TABLET, ORAL
Strength 2.5MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Aug 26, 2016

At a glance

  • 1–9 Submissions
  • 1–9 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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