Orange Book product

PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE 12MG;120MG

Orange Book ANDA 071455 · KV PHARMACEUTICAL CO · Discontinued

Key facts

Proprietary name PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
Active ingredients CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE
Strength 12MG;120MG
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Application ANDA071455
Applicant holder KV PHARMACEUTICAL CO
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 1, 1989

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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