Orange Book product

FURADANTIN 25MG/5ML

Orange Book NDA 009175 · CASPER PHARMA LLC · Prescription

Key facts

Proprietary name FURADANTIN
Active ingredients NITROFURANTOIN
Strength 25MG/5ML
Dosage form SUSPENSION
Route ORAL
Application NDA009175
Applicant holder CASPER PHARMA LLC
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)

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