Orange Book product

CLONIDINE HYDROCHLORIDE 0.05MG

Orange Book ANDA 070923 · TP ANDA HOLDINGS LLC · Prescription

Key facts

Proprietary name CLONIDINE HYDROCHLORIDE
Active ingredients CLONIDINE HYDROCHLORIDE
Strength 0.05MG
Dosage form TABLET
Route ORAL
Application ANDA070923
Applicant holder TP ANDA HOLDINGS LLC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Apr 6, 2026

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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