Orange Book product

DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL

Orange Book ANDA 217794 · LUPIN LTD · Prescription

Key facts

Proprietary name DOXYCYCLINE HYCLATE
Active ingredients DOXYCYCLINE HYCLATE
Strength EQ 100MG BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA217794
Applicant holder LUPIN LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 14, 2024

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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