Orange Book product

GLYDO 2%

Orange Book ANDA 201094 · SAGENT PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name GLYDO
Active ingredients LIDOCAINE HYDROCHLORIDE
Strength 2%
Dosage form JELLY
Route TOPICAL
Application ANDA201094
Applicant holder SAGENT PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Apr 28, 2014

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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