Orange Book product

CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register…

Orange Book NDA 020793 · HIKMA PHARMACEUTICALS USA INC · Discontinued

Key facts

Proprietary name CAFCIT
Active ingredients CAFFEINE CITRATE
Strength EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form SOLUTION
Route ORAL
Application NDA020793
Applicant holder HIKMA PHARMACEUTICALS USA INC
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Apr 12, 2000

At a glance

  • None 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)

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