Orange Book product

CARBINOXAMINE MALEATE 4MG/5ML

Orange Book ANDA 040458 · GENUS LIFESCIENCES INC · Prescription

Key facts

Proprietary name CARBINOXAMINE MALEATE
Active ingredients CARBINOXAMINE MALEATE
Strength 4MG/5ML
Dosage form SOLUTION
Route ORAL
Application ANDA040458
Applicant holder GENUS LIFESCIENCES INC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Apr 25, 2003

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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