Orange Book product

LORATADINE 1MG/ML

Orange Book ANDA 077421 · LANNETT CO INC · Over the counter

Key facts

Proprietary name LORATADINE
Active ingredients LORATADINE
Strength 1MG/ML
Dosage form SYRUP
Route ORAL
Application ANDA077421
Applicant holder LANNETT CO INC
Marketing status Over the counter
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 29, 2006

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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