Orange Book product

CLEOCIN HYDROCHLORIDE EQ 75MG BASE

Orange Book NDA 050162 · PFIZER INC · Prescription

Key facts

Proprietary name CLEOCIN HYDROCHLORIDE
Active ingredients CLINDAMYCIN HYDROCHLORIDE
Strength EQ 75MG BASE
Dosage form CAPSULE
Route ORAL
Application NDA050162
Applicant holder PFIZER INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jan 1, 1982

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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)

Browse all Orange Book products