Orange Book product

VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL

Orange Book ANDA 215821 · HAINAN POLY PHARM CO LTD · Prescription

Key facts

Proprietary name VANCOMYCIN HYDROCHLORIDE
Active ingredients VANCOMYCIN HYDROCHLORIDE
Strength EQ 10GM BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA215821
Applicant holder HAINAN POLY PHARM CO LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 18, 2021

At a glance

  • 10–99 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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