Orange Book product

HYDROXYZINE HYDROCHLORIDE 10MG/5ML

Orange Book ANDA 201674 · LANNETT CO INC · Prescription

Key facts

Proprietary name HYDROXYZINE HYDROCHLORIDE
Active ingredients HYDROXYZINE HYDROCHLORIDE
Strength 10MG/5ML
Dosage form SYRUP
Route ORAL
Application ANDA201674
Applicant holder LANNETT CO INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 21, 2013

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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