Drug application

ATROPINE SULFATE (ATROPINE SULFATE)

Drugs@FDA ANDA 215005 · SOMERSET THERAPS LLC

Key facts

Drug name ATROPINE SULFATE
Active ingredients ATROPINE SULFATE
Application type ANDA
Application number 215005
Company SOMERSET THERAPS LLC
Dosage forms SOLUTION, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL
Strength 8MG/20ML (0.4MG/ML)
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Nov 29, 2024

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

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

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