Orange Book product

BENZTROPINE MESYLATE 1MG

Orange Book ANDA 081265 · CHARTWELL RX SCIENCES LLC · Prescription

Key facts

Proprietary name BENZTROPINE MESYLATE
Active ingredients BENZTROPINE MESYLATE
Strength 1MG
Dosage form TABLET
Route ORAL
Application ANDA081265
Applicant holder CHARTWELL RX SCIENCES LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 23, 1992

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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