Orange Book product

CLONIDINE HYDROCHLORIDE 0.3MG

Orange Book ANDA 202297 · YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD · Prescription

Key facts

Proprietary name CLONIDINE HYDROCHLORIDE
Active ingredients CLONIDINE HYDROCHLORIDE
Strength 0.3MG
Dosage form TABLET
Route ORAL
Application ANDA202297
Applicant holder YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 13, 2013

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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