Orange Book product

CHLORPHENIRAMINE MALEATE 12MG

Orange Book ANDA 040829 · AVANTHI INC · Over the counter

Key facts

Proprietary name CHLORPHENIRAMINE MALEATE
Active ingredients CHLORPHENIRAMINE MALEATE
Strength 12MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA040829
Applicant holder AVANTHI INC
Marketing status Over the counter
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 13, 2009

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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