Drug application

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE and 1 more)

Drugs@FDA ANDA 040422 · BARR

Key facts

Drug name DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Active ingredients AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE
Application type ANDA
Application number 040422
Company BARR
Dosage forms TABLET, ORAL
Strength 1.25MG;1.25MG;1.25MG;1.25MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Feb 11, 2002

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents
  • No FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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