Orange Book product

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER EQ 18MG BASE/ML

Orange Book ANDA 201692 · SANDOZ INC · Prescription

Key facts

Proprietary name CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
Active ingredients CLINDAMYCIN PHOSPHATE
Strength EQ 18MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA201692
Applicant holder SANDOZ INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 31, 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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