Orange Book product

BETHANECHOL CHLORIDE 25MG

Orange Book ANDA 040728 · CHARTWELL RX SCIENCES LLC · Prescription

Key facts

Proprietary name BETHANECHOL CHLORIDE
Active ingredients BETHANECHOL CHLORIDE
Strength 25MG
Dosage form TABLET
Route ORAL
Application ANDA040728
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 Oct 26, 2007

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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