Orange Book product

MAGNESIUM SULFATE 5GM/10ML (500MG/ML)

Orange Book ANDA 075151 · HOSPIRA INC · Prescription

Key facts

Proprietary name MAGNESIUM SULFATE
Active ingredients MAGNESIUM SULFATE
Strength 5GM/10ML (500MG/ML)
Dosage form SOLUTION
Route INTRAMUSCULAR, INTRAVENOUS
Application ANDA075151
Applicant holder HOSPIRA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Apr 25, 2000

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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