Orange Book product

MILRINONE LACTATE IN DEXTROSE 5% EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Orange Book ANDA 219170 · CAPLIN STERILES LTD · Prescription

Key facts

Proprietary name MILRINONE LACTATE IN DEXTROSE 5%
Active ingredients MILRINONE LACTATE
Strength EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
Dosage form INJECTABLE
Route INJECTION
Application ANDA219170
Applicant holder CAPLIN STERILES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 2, 2025

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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