Drug application

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE)

Drugs@FDA ANDA 077999 · PLD ACQUISITIONS LLC

Key facts

Drug name FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active ingredients FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Application type ANDA
Application number 077999
Company PLD ACQUISITIONS LLC
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 60MG; 120MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Feb 25, 2010

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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