Orange Book product

GRANISETRON HYDROCHLORIDE EQ 1MG BASE

Orange Book ANDA 078846 · DR REDDYS LABORATORIES LTD · Prescription

Key facts

Proprietary name GRANISETRON HYDROCHLORIDE
Active ingredients GRANISETRON HYDROCHLORIDE
Strength EQ 1MG BASE
Dosage form TABLET
Route ORAL
Application ANDA078846
Applicant holder DR REDDYS LABORATORIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 27, 2009

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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