Orange Book product

METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML

Orange Book ANDA 070623 · SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW · Discontinued

Key facts

Proprietary name METOCLOPRAMIDE HYDROCHLORIDE
Active ingredients METOCLOPRAMIDE HYDROCHLORIDE
Strength EQ 5MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA070623
Applicant holder SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 2, 1987

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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