Orange Book product

TRIHEXYPHENIDYL HYDROCHLORIDE 2MG

Orange Book ANDA 040254 · NOVITIUM PHARMA LLC · Prescription

Key facts

Proprietary name TRIHEXYPHENIDYL HYDROCHLORIDE
Active ingredients TRIHEXYPHENIDYL HYDROCHLORIDE
Strength 2MG
Dosage form TABLET
Route ORAL
Application ANDA040254
Applicant holder NOVITIUM PHARMA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 24, 1998

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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