Orange Book product

MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE

Orange Book ANDA 065131 · STRIDES PHARMA INTERNATIONAL AG · Prescription

Key facts

Proprietary name MINOCYCLINE HYDROCHLORIDE
Active ingredients MINOCYCLINE HYDROCHLORIDE
Strength EQ 100MG BASE
Dosage form TABLET
Route ORAL
Application ANDA065131
Applicant holder STRIDES PHARMA INTERNATIONAL AG
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Apr 16, 2003

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)

Browse all Orange Book products