Orange Book product

ESMOLOL HYDROCHLORIDE 1GM/100ML

Orange Book ANDA 214172 · HQ SPECIALTY PHARMA CORP · Prescription

Key facts

Proprietary name ESMOLOL HYDROCHLORIDE
Active ingredients ESMOLOL HYDROCHLORIDE
Strength 1GM/100ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA214172
Applicant holder HQ SPECIALTY PHARMA CORP
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 2, 2022

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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