Orange Book product

RITALIN LA 20MG

Orange Book NDA 021284 · SANDOZ INC · Prescription

Key facts

Proprietary name RITALIN LA
Active ingredients METHYLPHENIDATE HYDROCHLORIDE
Strength 20MG
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Application NDA021284
Applicant holder SANDOZ INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB1
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jun 5, 2002

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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