Orange Book product

UNI-DUR 600MG

Orange Book ANDA 089823 · SCHERING CORP · Discontinued

Key facts

Proprietary name UNI-DUR
Active ingredients THEOPHYLLINE
Strength 600MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA089823
Applicant holder SCHERING CORP
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 4, 1995

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No 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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