Orange Book product

MESTINON 60MG

Orange Book NDA 009829 · BAUSCH HEALTH US LLC · Prescription

Key facts

Proprietary name MESTINON
Active ingredients PYRIDOSTIGMINE BROMIDE
Strength 60MG
Dosage form TABLET
Route ORAL
Application NDA009829
Applicant holder BAUSCH HEALTH US LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jan 1, 1982

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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