Drug application

RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE)

Drugs@FDA NDA 021284 · SANDOZ

Key facts

Drug name RITALIN LA
Active ingredients METHYLPHENIDATE HYDROCHLORIDE
Application type NDA
Application number 021284
Company SANDOZ
Dosage forms CAPSULE, EXTENDED RELEASE, ORAL
Strength 20MG
Marketing status Prescription
TE codes AB1
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Jun 5, 2002

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes 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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