Orange Book product

CHLORPHENIRAMINE MALEATE 12MG

Orange Book ANDA 070797 · AUROLIFE PHARMA LLC · Discontinued

Key facts

Proprietary name CHLORPHENIRAMINE MALEATE
Active ingredients CHLORPHENIRAMINE MALEATE
Strength 12MG
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Application ANDA070797
Applicant holder AUROLIFE PHARMA LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 12, 1988

At a glance

  • None 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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