Orange Book product

MAGNESIUM SULFATE 10GM/20ML (500MG/ML)

Orange Book ANDA 202411 · HOSPIRA INC · Prescription

Key facts

Proprietary name MAGNESIUM SULFATE
Active ingredients MAGNESIUM SULFATE
Strength 10GM/20ML (500MG/ML)
Dosage form SOLUTION
Route INTRAMUSCULAR, INTRAVENOUS
Application ANDA202411
Applicant holder HOSPIRA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 14, 2015

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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