Orange Book product

RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML

Orange Book ANDA 078684 · NOSTRUM LABORATORIES INC · Discontinued

Key facts

Proprietary name RANITIDINE HYDROCHLORIDE
Active ingredients RANITIDINE HYDROCHLORIDE
Strength EQ 15MG BASE/ML
Dosage form SYRUP
Route ORAL
Application ANDA078684
Applicant holder NOSTRUM LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 27, 2009

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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