Orange Book product

TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL

Orange Book ANDA 201166 · MEITHEAL PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name TOPOTECAN HYDROCHLORIDE
Active ingredients TOPOTECAN HYDROCHLORIDE
Strength EQ 4MG BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA201166
Applicant holder MEITHEAL PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 8, 2012

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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