Orange Book product

DEXTROAMPHETAMINE SULFATE 10MG

Orange Book ANDA 040367 · NESHER PHARMACEUTICALS USA LLC · Discontinued

Key facts

Proprietary name DEXTROAMPHETAMINE SULFATE
Active ingredients DEXTROAMPHETAMINE SULFATE
Strength 10MG
Dosage form TABLET
Route ORAL
Application ANDA040367
Applicant holder NESHER PHARMACEUTICALS USA LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 31, 2002

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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