Drug application

METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)

Drugs@FDA ANDA 040404 · ABLE

Key facts

Drug name METHYLPHENIDATE HYDROCHLORIDE
Active ingredients METHYLPHENIDATE HYDROCHLORIDE
Application type ANDA
Application number 040404
Company ABLE
Dosage forms TABLET, ORAL
Strength 5MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Mar 29, 2001

At a glance

  • 1–9 Submissions
  • 1–9 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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