Orange Book product

METHSCOPOLAMINE BROMIDE 2.5MG

Orange Book ANDA 216786 · NE RX PHARMA LLC · Prescription

Key facts

Proprietary name METHSCOPOLAMINE BROMIDE
Active ingredients METHSCOPOLAMINE BROMIDE
Strength 2.5MG
Dosage form TABLET
Route ORAL
Application ANDA216786
Applicant holder NE RX PHARMA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 1, 2024

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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