Orange Book product

GLYCOPYRROLATE 1MG

Orange Book ANDA 040568 · CHARTWELL RX SCIENCES LLC · Discontinued

Key facts

Proprietary name GLYCOPYRROLATE
Active ingredients GLYCOPYRROLATE
Strength 1MG
Dosage form TABLET
Route ORAL
Application ANDA040568
Applicant holder CHARTWELL RX SCIENCES LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 22, 2004

At a glance

  • 10–99 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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