Orange Book product

MONODOX EQ 50MG BASE

Orange Book NDA 050641 · CHARTWELL RX SCIENCES LLC · Prescription

Key facts

Proprietary name MONODOX
Active ingredients DOXYCYCLINE
Strength EQ 50MG BASE
Dosage form CAPSULE
Route ORAL
Application NDA050641
Applicant holder CHARTWELL RX SCIENCES LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Feb 10, 1992

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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