Orange Book product

CIMETIDINE 300MG

Orange Book ANDA 074340 · NOVITIUM PHARMA LLC · Discontinued

Key facts

Proprietary name CIMETIDINE
Active ingredients CIMETIDINE
Strength 300MG
Dosage form TABLET
Route ORAL
Application ANDA074340
Applicant holder NOVITIUM PHARMA LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 23, 1995

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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