Orange Book product

MALATHION 0.5%

Orange Book ANDA 091559 · SUVEN PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name MALATHION
Active ingredients MALATHION
Strength 0.5%
Dosage form LOTION
Route TOPICAL
Application ANDA091559
Applicant holder SUVEN PHARMACEUTICALS LTD
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 23, 2012

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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