Orange Book product

NEVIRAPINE 50MG/5ML

Orange Book ANDA 077702 · AUROBINDO PHARMA LTD · Prescription

Key facts

Proprietary name NEVIRAPINE
Active ingredients NEVIRAPINE
Strength 50MG/5ML
Dosage form SUSPENSION
Route ORAL
Application ANDA077702
Applicant holder AUROBINDO PHARMA LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 22, 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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