Orange Book product

RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML

Orange Book ANDA 079076 · MYLAN LABORATORIES LTD · Discontinued

Key facts

Proprietary name RANITIDINE HYDROCHLORIDE
Active ingredients RANITIDINE HYDROCHLORIDE
Strength EQ 25MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA079076
Applicant holder MYLAN LABORATORIES LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 9, 2016

At a glance

  • None 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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