Orange Book product

POLARAMINE 2MG/5ML

Orange Book ANDA 086837 · SCHERING CORP SUB SCHERING PLOUGH CORP · Discontinued

Key facts

Proprietary name POLARAMINE
Active ingredients DEXCHLORPHENIRAMINE MALEATE
Strength 2MG/5ML
Dosage form SYRUP
Route ORAL
Application ANDA086837
Applicant holder SCHERING CORP SUB SCHERING PLOUGH CORP
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 19, 1982

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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