Orange Book product

SODIUM BICARBONATE 44.6MEQ/50ML (0.9MEQ/ML)

Orange Book ANDA 202494 · HOSPIRA INC · Prescription

Key facts

Proprietary name SODIUM BICARBONATE
Active ingredients SODIUM BICARBONATE
Strength 44.6MEQ/50ML (0.9MEQ/ML)
Dosage form SOLUTION
Route INTRAVENOUS
Application ANDA202494
Applicant holder HOSPIRA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 6, 2017

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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