Orange Book product

MANNITOL 25% 12.5GM/50ML

Orange Book NDA 016269 · HOSPIRA INC · Prescription

Key facts

Proprietary name MANNITOL 25%
Active ingredients MANNITOL
Strength 12.5GM/50ML
Dosage form INJECTABLE
Route INJECTION
Application NDA016269
Applicant holder HOSPIRA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 25, 1994

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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