Orange Book product

BUDESONIDE 1MG/2ML

Orange Book ANDA 205710 · CIPLA LTD · Prescription

Key facts

Proprietary name BUDESONIDE
Active ingredients BUDESONIDE
Strength 1MG/2ML
Dosage form SUSPENSION
Route INHALATION
Application ANDA205710
Applicant holder CIPLA LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AN
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 16, 2017

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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